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Li J, Wang Z, Chandra A, Xu J, Liu L, Zhao M. The effectiveness of vitrectomy co-adjuvant intravitreal dexamethasone implant on visual outcome in patients with proliferative diabetic retinopathy: study protocol for a prospective randomized controlled trial. Trials 2025; 26:51. [PMID: 39939840 PMCID: PMC11823229 DOI: 10.1186/s13063-025-08758-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2023] [Accepted: 01/28/2025] [Indexed: 02/14/2025] Open
Abstract
BACKGROUND Proliferative diabetic retinopathy (PDR) often leads to tractional retinal detachment and vitreous hemorrhage, requiring vitrectomy. Poor visual outcomes are commonly caused by macular edema and proliferative vitreous retinopathy after vitrectomy. Intravitreal dexamethasone implant has shown promise in improving visual function after vitrectomy for diabetic macular edema, but its role in vitrectomy for PDR treatment remains unexplored. This study aims to assess the effectiveness of vitrectomy combined with an intravitreal dexamethasone implant for PDR patients. METHODS We will design a single-mask, randomized controlled trial with 100 participants diagnosed with PDR requiring vitrectomy. Participants will be randomly assigned to either the Ozurdex (0.7 mg dexamethasone intravitreal implant) group or the control group. The dexamethasone implant group will undergo vitrectomy combined with 0.7 mg dexamethasone intravitreal implant, while the control group will undergo vitrectomy alone. A single surgeon will perform all the vitrectomy surgeries, and the choice of intravitreal dexamethasone implant treatment will be disclosed before the closure of scleral wounds. Primary and secondary outcomes will be assessed at baseline and at 4, 8, 12, and 24 weeks post-vitrectomy. STATISTICAL ANALYSIS Statistical analysis will be conducted using R software. A p value 0.05 will be considered statistically significant. The analysis methods will include the following: visual acuity and OCT measurements will be analyzed using repeated measures analysis of variance (ANOVA) with two-tailed tests; rates of visual improvement, visual decline, postoperative vitreous hemorrhage, elevated intraocular pressure, and postoperative retinal detachment will be analyzed using chi-square tests with two-tailed tests. Logistic regression analysis will be used to analyze risk factors for poor visual prognosis, neovascular glaucoma development, and postoperative vitreous hemorrhage occurrence. DISCUSSION This protocol aims to enhance our understanding of the effects of combining an intravitreal Ozurdex 0.7 mg dexamethasone implant with vitrectomy on visual outcomes and macular morphology changes in treating late complications of PDR. TRIAL REGISTRATION The trial was registered at the Chinese Clinical Trial Registry on May 11, 2022, with registration number ChiCTR2200059760.
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Affiliation(s)
- Jipeng Li
- Ophthalmology, Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China
| | - Zhaoyang Wang
- Ophthalmology, Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China
| | - Aman Chandra
- Mid & South Essex NHS Foundation Trust (Southend University Hospital) , Prittlewell Chase, Essex, SS00RY, UK
- Anglia Ruskin University, Cambridge, UK
| | - Jun Xu
- Ophthalmology, Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China
| | - Lin Liu
- Ophthalmology, Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China
| | - Meng Zhao
- Ophthalmology, Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.
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Arora A, Morya AK, Gupta PC, Menia NK, Nishant P, Gupta V. Intravitreal therapy for the management of diabetic retinopathy: A concise review. World J Exp Med 2024; 14:99235. [PMID: 39713073 PMCID: PMC11551706 DOI: 10.5493/wjem.v14.i4.99235] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Revised: 09/08/2024] [Accepted: 09/20/2024] [Indexed: 10/31/2024] Open
Abstract
Diabetic retinopathy (DR) is a serious microvascular complication of diabetes mellitus and may result in irreversible visual loss. Laser treatment has been the gold standard treatment for diabetic macular edema and proliferative diabetic retinopathy for many years. Of late, intravitreal therapy has emerged as a cornerstone in the management of DR. Among the diverse pharmacotherapeutic options, anti-vascular endothelial growth factor agents have demonstrated remarkable efficacy by attenuating neovascularization and reducing macular edema, thus preserving visual acuity in DR patients.
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Affiliation(s)
- Atul Arora
- Teleophthalmology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, Punjab, India
| | - Arvind K Morya
- Department of Ophthalmology, All India Institute of Medical Sciences, Hyderabad 508126, Telangana, India
| | - Parul C Gupta
- Department of Ophthalmology, Post Graduate Institute of Medical Education & Research, Chandigarh 160012, Punjab, India
| | - Nitin K Menia
- Department of Ophthalmology, All India Institute of Medical Sciences, Vijaypur 180001, Jammu and Kashmīr, India
| | - Prateek Nishant
- Department of Ophthalmology, ESIC Medical College, Patna 801103, Bihār, India
| | - Vishali Gupta
- Department of Ophthalmology, Post Graduate Institute of Medical Education & Research, Chandigarh 160012, Punjab, India
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Oliverio GW, Meduri A, Brancati VU, Ingrande I, De Luca L, Raimondo ED, Minutoli L, Aragona E, Aragona P. Clinical and optical coherence tomography biomarkers as prognostic factors in dexamethasone intravitreal implant for diabetic macular edema. Eur J Ophthalmol 2024; 34:1810-1818. [PMID: 38384119 DOI: 10.1177/11206721241235242] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/23/2024]
Abstract
PURPOSE Aim of the study was to evaluate the efficacy of dexamethasone (DEX) 0.7 mg intravitreal implant in patients with diabetic macular edema (DME) and serous retinal detachment (SRD), and to study the prognostic factors on a follow up of 12 months. METHODS Forty eyes of twenty- six patients with centre involving DME and SRD, who underwent DEX implant, were enrolled. Best-corrected visual acuity (BCVA), Swept source OCT imaging and intraocular pressure were evaluated. Central macular thickness (CMT), vitreomacular adhesion (VMA), disorganization of retinal inner layers (DRILs), hyperreflective dots (HRD), SRD and ellipsoid zone (EZ) disruption were included in the analysis at baseline and 12 months after implant. RESULTS According to our parametric analysis, at 12 months, BVCA improvement from 48.6 ± 23.4 letters to 53.3 ± 24.5 letters was statistically significant (p = 0.04), CMT decreased from 460 ± 99.52 μm to 322.9 ± 117 μm. The presence at baseline of VMA (p = 0.01), EZ disruption (p = 0.03) and DRILs (p = 0.04), were associated with poor BCVA improvement at the end of follow-up. CONCLUSION In conclusion, OCT biomarkers can be considered significant prognostic factors for treatment outcome in patients with DME undergoing DEX intravitreal implant.
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Affiliation(s)
- Giovanni William Oliverio
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
| | - Alessandro Meduri
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
| | | | - Irene Ingrande
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
| | - Laura De Luca
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
| | - Enrico Di Raimondo
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
| | - Letteria Minutoli
- Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
| | - Emanuela Aragona
- IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy
| | - Pasquale Aragona
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
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Nawar AE, Ali AYA, Massoud OM, Alagorie AR. Effectiveness of Suprachoroidal Injection of Triamcinolone Acetonide in Diabetic Macular Edema Following Pars Plana Vitrectomy Using a Modified Custom Microneedle. Clin Ophthalmol 2024; 18:2049-2060. [PMID: 39051023 PMCID: PMC11268719 DOI: 10.2147/opth.s472910] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2024] [Accepted: 06/28/2024] [Indexed: 07/27/2024] Open
Abstract
Purpose The present study evaluated the efficacy of suprachoroidal injection of Triamcinolone Acetonide (SCTA) in diabetic macular edema (DME) following pars plana vitrectomy (PPV) using a modified microneedle. Patients and methods A prospective interventional study was conducted on 60 eyes of 60 patients with centrally involved diabetic macular edema following pars plana vitrectomy (PPV). SCTA was performed at the baseline and repeated after 3 months in case of persistent subretinal or intraretinal fluid, central macular thickness (CMT) more than 300 µm or visual loss by more than one line of the Snellen chart. Results The present study detected significant reduction of the CMT from 498.3 ± 94.8 µm at the baseline to 212.3 ± 11.9 µm after 12 months of injection with p < 0.001 and a significant improvement of best corrected visual acuity (BCVA) from 1 (0.9-1.2) at the baseline to 0.5 (0.3-0.7) after 12 months of injection with p < 0.001. The intraocular pressure (IOP) increased significantly after 3 months of injection with p < 0.001 and then gradually declined to its normal level after 6 months. Inner segment/outer segment (IS/OS) disruption was the only significant predictor of the final CMT; however, the number of injections, IS/OS disruption, baseline BCVA and the HbA1C level were the significant predictors of the final BCVA after injection. Conclusion Suprachoroidal injection of TA using this microneedle resulted in significant anatomical and functional improvement in previously vitrectomized diabetic macular edema patients with no recorded ocular or systemic adverse events.
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Affiliation(s)
- Amin E Nawar
- Ophthalmology Department, Faculty of Medicine, Tanta University, Tanta, Egypt
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Liu S, Yan Z, Huang Z, Yang H, Li J. Smart Nanocarriers for the Treatment of Retinal Diseases. ACS APPLIED BIO MATERIALS 2024; 7:2070-2085. [PMID: 38489843 DOI: 10.1021/acsabm.3c01289] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/17/2024]
Abstract
Retinal diseases, such as age-related macular degeneration, diabetic retinopathy, and retinoblastoma, stand as the leading causes of irreversible vision impairment and blindness worldwide. Effectively administering drugs for retinal diseases poses a formidable challenge due to the presence of complex ocular barriers and elimination mechanisms. Over time, various approaches have been developed to fabricate drug delivery systems for improving retinal therapy including virus vectors, lipid nanoparticles, and polymers. However, conventional nanocarriers encounter issues related to the controllability, efficiency, and safety in the retina. Therefore, the development of smart nanocarriers for effective or more invasive long-term treatment remains a desirable goal. Recently, approaches have surfaced for the intelligent design of nanocarriers, leveraging specific responses to external or internal triggers and enabling multiple functions for retinal therapy such as topical administration, prolonged drug release, and site-specific drug delivery. This Review provides an overview of prevalent retinal pathologies and related pharmacotherapies to enhance the understanding of retinal diseases. It also surveys recent developments and strategies employed in the intelligent design of nanocarriers for retinal disease. Finally, the challenges of smart nanocarriers in potential clinical retinal therapeutic applications are discussed to inspire the next generation of smart nanocarriers.
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Affiliation(s)
- Shuya Liu
- MOE Key Laboratory for Analytical Science of Food Safety and Biology, Fujian Provincial Key Laboratory of Analysis and Detection Technology for Food Safety, College of Chemistry, Fuzhou University, Fuzhou 350116, P. R. China
| | - Zhike Yan
- MOE Key Laboratory for Analytical Science of Food Safety and Biology, Fujian Provincial Key Laboratory of Analysis and Detection Technology for Food Safety, College of Chemistry, Fuzhou University, Fuzhou 350116, P. R. China
| | - Zixiang Huang
- MOE Key Laboratory for Analytical Science of Food Safety and Biology, Fujian Provincial Key Laboratory of Analysis and Detection Technology for Food Safety, College of Chemistry, Fuzhou University, Fuzhou 350116, P. R. China
| | - Huanghao Yang
- MOE Key Laboratory for Analytical Science of Food Safety and Biology, Fujian Provincial Key Laboratory of Analysis and Detection Technology for Food Safety, College of Chemistry, Fuzhou University, Fuzhou 350116, P. R. China
| | - Jingying Li
- College of Biological Science and Engineering, Fuzhou University, Fuzhou 350116, P. R. China
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Baldascino A, Carlà MM, Vielmo L, Gambini G, Marzano FC, Margollicci F, D’Onofrio NC, Rizzo S. Microvascular Changes after Epiretinal Membrane Vitrectomy with Intraoperative Intravitreal Dexamethasone Implant: An OCT Angiography Analysis. Diagnostics (Basel) 2024; 14:411. [PMID: 38396450 PMCID: PMC10888329 DOI: 10.3390/diagnostics14040411] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2024] [Revised: 02/04/2024] [Accepted: 02/12/2024] [Indexed: 02/25/2024] Open
Abstract
BACKGROUND We aimed to explore microvascular changes evaluated with optical coherence tomography angiography (OCTA) in patients undergoing epiretinal membrane (ERM) pars-plana vitrectomy (PPV) combined with intravitreal Ozurdex implantation, compared with standard PPV. (2) Methods: Prospective interventional analysis on 25 eyes undergoing PPV + Ozurdex (Group A) and 25 eyes undergoing PPV alone. Best corrected visual acuity (BCVA) and OCTA parameters, such as vessel density (VD) of the superficial and deep capillary plexi (SCP and DCP) in the whole 6.4 mm × 6.4 mm and fovea area, were evaluated preoperatively and 3 months after surgery. (3) Results: Postoperative BCVA significantly improved in both groups. No cases of post-operative cystoid macular edema (CME) were reported in Group A vs. two eyes in Group B. In Group A we found a statistically significant increase of SCP's VD in either the whole image (from 42.1 ± 4.1 to 45.6 ± 4.3%, p = 0.01) and the fovea image (from 38.5 ± 7.5 to 41.7 ± 4.2%, p = 0.03). In Group B, we reported no significant variations in the SCP's VDs. In the DCP, VD significantly increased only in the whole image in Group A. Stage 4 ERMs showed the greatest improvement in VD, especially in Group A. (4) Conclusions: Intraoperative Ozurdex prompted a significant BCVA recovery and limited the occurrence of postoperative CME compared to the standard procedure. Moreover, Ozurdex implant is associated with a better restoration of microvascular structure in SCP and DCP.
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Affiliation(s)
- Antonio Baldascino
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
| | - Matteo Mario Carlà
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
| | - Lorenzo Vielmo
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
| | - Gloria Gambini
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
| | | | - Fabio Margollicci
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
| | - Nicola Claudio D’Onofrio
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
| | - Stanislao Rizzo
- Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy; (A.B.); (G.G.); (F.M.); (N.C.D.); (S.R.)
- Ophthalmology Unit, Catholic University “Sacro Cuore”, 00168 Rome, Italy
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Ozsaygılı C, Bayram N. Does dexamethasone implant combination with aflibercept monotherapy affect one-year outcomes in treatment-naive diabetic macular edema with inflammatory biomarkers? Int Ophthalmol 2024; 44:51. [PMID: 38336941 DOI: 10.1007/s10792-024-02963-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2023] [Accepted: 12/04/2023] [Indexed: 02/12/2024]
Abstract
PURPOSE To compare the anatomical and functional outcomes of the combination of aflibercept and dexamethasone implant (CT) against aflibercept monotherapy (AM) in treatment-naive diabetic macular edema (DME) patients with serous macular detachment and hyperreflective foci. METHODS This study included 82 eyes of 82 patients with treatment-naive DME who completed the follow-up period of 12 months. All patients had optical coherence tomography biomarkers of an inflammatory DME phenotype. Patients were consecutively selected and classified into two groups: The CT group consisted of 39 eyes treated with aflibercept therapy and initially combined with a single-dose dexamethasone implant. The AM group consisted of 43 eyes treated with aflibercept alone. The primary outcome measures of the study were the mean reduction of the central macular thickness (CMT) and total macular volume parameters (TMV) and improvement in best-corrected visual acuity. RESULTS In both groups, the patient characteristics, including age, gender, duration of diabetes, HbA1c levels, phakic percentage, and diabetic retinopathy status were similar (P > 0.05). The mean reduction in CMT and TMV was significantly higher in the CT group compared to the AM group (P < 0.001 and P = 0.002, respectively). In contrast, mean letter gains were not significantly higher (P = 0.240) at the end of the study. In the CT group, 20.5% of patients showed a transient IOP increase, and 18% developed cataracts. In subgroup analysis, the mean letter gain in pseudophakic eyes was significantly higher (12.5 in the CT vs. 9.3 in the AM group, P = 0.027). CONCLUSION The CT, where inflammation is prominent, can provide faster recovery. The pseudophakic eyes seem to be the ideal patient group for CT.
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Affiliation(s)
- Cemal Ozsaygılı
- Department of Ophthalmology, University of Health Sciences, Kayseri City Training and Research Hospital, Kocasinan, Kayseri, Turkey.
| | - Nurettin Bayram
- University of Health Sciences, Ankara Etlik City Hospital, Yenimahalle, Ankara, Turkey
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Taloni A, Coco G, Rastelli D, Buffon G, Scorcia V, Giannaccare G. Safety and Efficacy of Dexamethasone Intravitreal Implant Given Either First-Line or Second-Line in Diabetic Macular Edema. Patient Prefer Adherence 2023; 17:3307-3329. [PMID: 38106365 PMCID: PMC10725633 DOI: 10.2147/ppa.s427209] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2023] [Accepted: 12/06/2023] [Indexed: 12/19/2023] Open
Abstract
Diabetic macular edema (DME) is a common sight-threatening complication of diabetic retinopathy (DR) and the leading cause of severe visual impairment among the working-age population. Several therapeutic options are available for the management of DME, including intravitreal corticosteroids. They have been traditionally used as second-line treatment, due to the risk of intraocular pressure increase and cataract-related adverse events. However, attention has recently been focused on the primary or early use of intravitreal corticosteroids, due to growing evidence of the crucial role of inflammation in the pathogenesis of DME. Furthermore, intravitreal steroid implants offer the additional advantage of a longer duration of action compared to anti-vascular endothelial growth factor agents (anti-VEGF). This review aims to summarize the available evidence on the efficacy and safety profile of dexamethasone (DEX) intravitreal implant, with a specific focus on clinical scenarios in which it might be considered or even preferred as first-line treatment option by adequate selection of patients, considering both advantages and possible adverse events. Patients with contraindications to anti-VEGF, DME with high inflammatory OCT biomarkers, pseudophakic patients and phakic patients' candidates to cataract surgery as well as vitrectomized eyes may all benefit from first-line DEX implant. Additionally, DME not responders to anti-VEGF should be considered for a switch to DEX implant and a combination therapy of DEX implant and anti-VEGF could be a valid option in severe and persistent DME.
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Affiliation(s)
- Andrea Taloni
- Department of Ophthalmology, University “Magna Graecia” of Catanzaro, Catanzaro, Italy
| | - Giulia Coco
- Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Rome, Italy
| | - Davide Rastelli
- Department of Ophthalmology, Policlinico Casilino, Rome, Italy
| | - Giacinta Buffon
- Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Rome, Italy
| | - Vincenzo Scorcia
- Department of Ophthalmology, University “Magna Graecia” of Catanzaro, Catanzaro, Italy
| | - Giuseppe Giannaccare
- Eye Clinic, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
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Gabrielle PH, Mehta H, Barthelmes D, Daien V, Nguyen V, Gillies MC, Creuzot-Garcher CP. From randomised controlled trials to real-world data: Clinical evidence to guide management of diabetic macular oedema. Prog Retin Eye Res 2023; 97:101219. [PMID: 37898362 DOI: 10.1016/j.preteyeres.2023.101219] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2023] [Revised: 10/12/2023] [Accepted: 10/13/2023] [Indexed: 10/30/2023]
Abstract
Randomised clinical trials (RCTs) are generally considered the gold-standard for providing scientific evidence for treatments' effectiveness and safety but their findings may not always be generalisable to the broader population treated in routine clinical practice. RCTs include highly selected patient populations that fit specific inclusion and exclusion criteria. Although they may have a lower level of certainty than RCTs on the evidence hierarchy, real-world data (RWD), such as observational studies, registries and databases, provide real-world evidence (RWE) that can complement RCTs. For example, RWE may help satisfy requirements for a new indication of an already approved drug and help us better understand long-term treatment effectiveness, safety and patterns of use in clinical practice. Many countries have set up registries, observational studies and databases containing information on patients with retinal diseases, such as diabetic macular oedema (DMO). These DMO RWD have produced significant clinical evidence in the past decade that has changed the management of DMO. RWD and medico-administrative databases are a useful resource to identify low frequency safety signals. They often have long-term follow-up with a large number of patients and minimal exclusion criteria. We will discuss improvements in healthcare information exchange technologies, such as blockchain technology and FHIR (Fast Healthcare Interoperability Resources), which will connect and extend databases already available. These registries can be linked with existing or emerging retinal imaging modalities using artificial intelligence to aid diagnosis, treatment decisions and provide prognostic information. The results of RCTs and RWE are combined to provide evidence-based guidelines.
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Affiliation(s)
- Pierre-Henry Gabrielle
- Department of Ophthalmology, Dijon University Hospital, Dijon, Burgundy, France; The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
| | - Hemal Mehta
- The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia; Ophthalmology Department, Royal Free London NHS Foundation Trust, London, United Kingdom
| | - Daniel Barthelmes
- The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia; Department of Ophthalmology, University Hospital and University of Zurich, Zurich, Switzerland
| | - Vincent Daien
- The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia; Department of Ophthalmology, Montpellier University Hospital, Montpellier, France; Institute for Neurosciences of Montpellier, Univ Montpellier, INSERM, Montpellier, France
| | - Vuong Nguyen
- The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
| | - Mark C Gillies
- The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
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Spinetta R, Petrillo F, Reibaldi M, Tortori A, Mazzoni M, Metrangolo C, Gelormini F, Ricardi F, Giordano A. Intravitreal DEX Implant for the Treatment of Diabetic Macular Edema: A Review of National Consensus. Pharmaceutics 2023; 15:2461. [PMID: 37896220 PMCID: PMC10610055 DOI: 10.3390/pharmaceutics15102461] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2023] [Revised: 09/16/2023] [Accepted: 09/26/2023] [Indexed: 10/29/2023] Open
Abstract
Diabetic macular edema (DME)'s therapeutic approach can frequently be challenging. The purpose of the review is to propose evidence-based recommendations on the employment of intravitreal dexamethasone implants (DEX) when approaching patients suffering from DME. Seven national consensuses redacted by different groups of retina specialists from Europe and Asia were examined and confronted. Each consensus was redacted utilizing a Delphi approach, in person meetings, or by reviewing the literature. DEX can be studied as a first-line strategy in individuals suffering from DME with inflammatory OCT biomarkers, in vitrectomized eyes, in patients with recent cardiovascular events, in pregnant women, in patients scheduled to undergo cataract surgery or with poor compliance. The other parameters considered were the indications to the DME treatment, when to switch to DEX, the definition of non-responder to anti-VEGFs agents and to the DEX implant, whether to combine DEX with laser photocoagulation, the association between glaucoma and DEX, and the management of DEX and the cataract. Although several years have passed since the introduction of DEX implants in the DME treatment, there is still not a unified agreement among retina specialists. This paper compares the approach in the DME treatment between countries from different continents and provides a broader and worldwide perspective of the topic.
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Affiliation(s)
| | - Francesco Petrillo
- Department of Medical Sciences, Eye Clinic, Turin University, 10024 Turin, Italy; (M.R.); (F.G.); (F.R.)
| | - Michele Reibaldi
- Department of Medical Sciences, Eye Clinic, Turin University, 10024 Turin, Italy; (M.R.); (F.G.); (F.R.)
| | - Antonia Tortori
- Ophthalmology Unit, Surgery Department, Piacenza Hospital, 29121 Piacenza, Italy;
| | - Maria Mazzoni
- University Center for Studies on Gender Medicine, University of Ferrara, 44124 Ferrara, Italy;
- Department of Neuroscience and Rehabilitation, University of Ferrara, 44121 Ferrara, Italy
| | - Cristian Metrangolo
- Ophthalmology Unit, Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, 21100 Varese, Italy;
| | - Francesco Gelormini
- Department of Medical Sciences, Eye Clinic, Turin University, 10024 Turin, Italy; (M.R.); (F.G.); (F.R.)
| | - Federico Ricardi
- Department of Medical Sciences, Eye Clinic, Turin University, 10024 Turin, Italy; (M.R.); (F.G.); (F.R.)
| | - Antonio Giordano
- Sbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple University, Philadelphia, PA 19122, USA;
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Hsu CR, Hsieh YT, Yang CM, Lin CP. Single-dose Effect of Intravitreal Dexamethasone Implant for Post-vitrectomy Macular Edema under Silicone Oil. Ocul Immunol Inflamm 2023; 31:1587-1593. [PMID: 34477484 DOI: 10.1080/09273948.2021.1970779] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2021] [Accepted: 08/16/2021] [Indexed: 10/20/2022]
Abstract
PURPOSE To investigate the single-dose effect of intravitreal dexamethasone (DEX) implant for patients with post-vitrectomy macular edema (ME) under silicone oil (SO) tamponade. METHODS Twelve eyes diagnosed with ME after undergoing pars plana vitrectomy with SO injections were retrospectively reviewed. Each eye received a single intravitreal DEX implant (0.7-mg, Ozurdex; Allergan Inc) injection as treatment for recalcitrant ME. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were recorded. RESULTS Compared with baseline (1.24 ± 0.34), the mean LogMAR BCVA improved at 1 (1.14 ± 0.27), 3 (1.13 ± 0.22), and 6 (1.22 ± 0.30) months without statistical significance. Maximal CMT resolution was observed at 1 month after intravitreal injection. The CMT value improved significantly at 1 (P = .008), 3 (P = .006), and 6 (P = .009) months. IOP did not show significant elevation during follow-up. No serious adverse events were observed. CONCLUSION Single-dose treatment of DEX implant may have benefit for recalcitrant post-vitrectomy ME under SO tamponade.
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Affiliation(s)
- Cherng-Ru Hsu
- Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan
- Department of Ophthalmology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
| | - Yi-Ting Hsieh
- Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan
- Department of Ophthalmology, National Taiwan University College of Medicine, Taipei, Taiwan
| | - Chung-May Yang
- Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan
- Department of Ophthalmology, National Taiwan University College of Medicine, Taipei, Taiwan
| | - Chang-Ping Lin
- Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan
- Department of Ophthalmology, National Taiwan University College of Medicine, Taipei, Taiwan
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12
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Li S, Zeng Q, Zhu L, Liu W, Li Y, Li J, Li X, Zhao M, Qu J. Intraoperative slow-release dexamethasone intravitreal implant (Ozurdex) in epiretinal membrane peeling surgery: a prospective randomized controlled trial. Front Pharmacol 2023; 14:1219861. [PMID: 37727387 PMCID: PMC10505737 DOI: 10.3389/fphar.2023.1219861] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2023] [Accepted: 08/21/2023] [Indexed: 09/21/2023] Open
Abstract
Purpose: This study aimed to determine the efficacy of the dexamethasone (DEX) intravitreal implant for the regression of macular edema and the improvement of best-corrected visual acuity (BCVA) after the removal of idiopathic epiretinal membrane (ERM). Methods: This prospective randomized controlled trial recruited 81 patients with idiopathic ERM. These patients all underwent 25-gauge pars plana vitrectomy combined with ERM and internal limiting membrane peeling surgery. Among them, 41 eyes in the DEX group received additional DEX implants and 40 in the non-DEX group did not. Outcomes including central retinal thickness (CRT), BCVA, and intraocular pressure were measured 1 and 3 months after surgery. Results: The DEX group had thinner CRTs compared to the non-DEX group at 1 month postoperatively (p <0.05), but did not differ significantly at the 1-week and 3-month follow-up visits (p = 0.109 and p = 0.417, respectively). There were no statistical differences with respect to BCVA (p = 0.499, 0.309, 0.246, and 0.517, respectively) and intraocular pressure (p = 0.556, 0.639, 0.741, and 0.517, respectively) between the two groups at each point of follow-up visits. Conclusion: DEX accelerated the reduction of CRT at 1 month after surgery. However, no evidence of further anatomical (CRT) or functional (BCVA) benefits using DEX was observed at 3 months. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT05416827.
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Affiliation(s)
| | | | | | | | | | | | | | | | - Jinfeng Qu
- Department of Ophthalmology, Peking University People’s Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing, China
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13
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Lai CC, Kuo SC. Real-world experience on intravitreal dexamethasone implant in patients with macular edema scheduled to undergo cataract surgery. BMC Ophthalmol 2023; 23:352. [PMID: 37559002 PMCID: PMC10413593 DOI: 10.1186/s12886-023-03093-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2023] [Accepted: 07/22/2023] [Indexed: 08/11/2023] Open
Abstract
BACKGROUND Patients with pre-existing macular edema (ME) due to diabetes and retinal vein occlusions (RVO) make up a growing population receiving cataract surgery. Surgery is associated with an increased risk of worsening existing ME due to post-surgical inflammation that can be further exacerbated by pre-existing diabetic retinopathy (DR) and retinal vein occlusion. This study aimed to examine the pre-operative use of intravitreal dexamethasone (DEX) implants in patients with ME undergoing cataract surgery. METHODS A retrospective study was conducted at National Cheng Kung University Hospital in Taiwan involving 19 eyes of 16 patients with DME or ME associated with RVO. All participants received a DEX implant at baseline and underwent phacoemulsification within 3 months after its insertion. Best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central subfield thickness (CST) were evaluated. RESULTS DEX implants reduced the CST from baseline (357.8 μm) to pre-surgery (280.8 μm). This reduction below baseline continued to month 6 post-surgery (319.4 μm). From baseline (16.15 mmHg), the mean IOP initially increased pre-surgery (17.78 mmHg) before returning to the baseline value at month 6 post-surgery (16.15 mmHg). All patients improved their BCVA from logMAR 0.943 on average at baseline to logMAR 0.532 at month 6 post-surgery. CONCLUSIONS The results of the study suggested that patients with ME could benefit from DEX implants before cataract surgery within 3 months to achieve sufficient postoperative inflammation management and limit ME deterioration. DEX implants did not increase IOP post-surgery and was similar to baseline levels.
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Affiliation(s)
- Chun-Chieh Lai
- Department of Ophthalmology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
- Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan
| | - Shu-Chun Kuo
- Department of Ophthalmology, Chi Mei Medical Center, Tainan, Taiwan.
- Department of Optometry, Chung Hwa University of Medical Technology, No. 901, Zhonghua Rd, Yongkang District, Tainan City, 710, Taiwan.
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14
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Pastorin G, Benetti C, Wacker MG. From in vitro to in vivo: A comprehensive guide to IVIVC development for long-acting therapeutics. Adv Drug Deliv Rev 2023; 199:114906. [PMID: 37286087 DOI: 10.1016/j.addr.2023.114906] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2022] [Revised: 05/22/2023] [Accepted: 05/31/2023] [Indexed: 06/09/2023]
Affiliation(s)
- Giorgia Pastorin
- Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.
| | - Camillo Benetti
- Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore
| | - Matthias G Wacker
- Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore
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Shughoury A, Bhatwadekar A, Jusufbegovic D, Hajrasouliha A, Ciulla TA. The evolving therapeutic landscape of diabetic retinopathy. Expert Opin Biol Ther 2023; 23:969-985. [PMID: 37578843 PMCID: PMC10592121 DOI: 10.1080/14712598.2023.2247987] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2023] [Revised: 07/30/2023] [Accepted: 08/11/2023] [Indexed: 08/16/2023]
Abstract
INTRODUCTION Diabetic retinopathy (DR) is a leading cause of blindness worldwide. Recent decades have seen rapid progress in the management of diabetic eye disease, evolving from pituitary ablation to photocoagulation and intravitreal pharmacotherapy. The advent of effective intravitreal drugs inhibiting vascular endothelial growth factor (VEGF) marked a new era in DR therapy. Sustained innovation has since produced several promising biologics targeting angiogenesis, inflammation, oxidative stress, and neurodegeneration. AREAS COVERED This review surveys traditional, contemporary, and emerging therapeutics for DR, with an emphasis on anti-VEGF therapies, receptor tyrosine kinase inhibitors, angiopoietin-Tie2 pathway inhibitors, integrin pathway inhibitors, gene therapy 'biofactory' approaches, and novel systemic therapies. Some of these investigational therapies are being delivered intravitreally via sustained release technologies for extended durability. Other investigational agents are being delivered non-invasively via topical and systemic routes. These strategies hold promise for early and long-lasting treatment of DR. EXPERT OPINION The evolving therapeutic landscape of DR is rapidly expanding our toolkit for the effective and durable treatment of blinding eye disease. However, further research is required to validate the efficacy of novel therapeutics and characterize real world outcomes.
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Affiliation(s)
- Aumer Shughoury
- Department of Ophthalmology, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, IN, USA 46202
| | - Ashay Bhatwadekar
- Department of Ophthalmology, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, IN, USA 46202
| | - Denis Jusufbegovic
- Department of Ophthalmology, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, IN, USA 46202
| | - Amir Hajrasouliha
- Department of Ophthalmology, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, IN, USA 46202
| | - Thomas A Ciulla
- Department of Ophthalmology, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, IN, USA 46202
- Midwest Eye Institute, Indianapolis, IN, USA 46290
- Clearside Biomedical, Inc., Alpharetta, GA, USA 30005
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16
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Pignatelli F, Niro A, Fallico M, Passidomo F, Gigliola S, Nacucchi A, Bonfiglio V, Reibaldi M, Addabbo G, Avitabile T. Mid-term safety and effectiveness of macular peeling one month after intravitreal dexamethasone implant for tractional diabetic macular edema. Sci Rep 2023; 13:5990. [PMID: 37045880 PMCID: PMC10097727 DOI: 10.1038/s41598-023-32780-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2022] [Accepted: 04/02/2023] [Indexed: 04/14/2023] Open
Abstract
Macular peeling combined or followed by intravitreal dexamethasone implant (DEX-i) was recommended as an efficacy approach for tractional diabetic macular edema (tDME). Knowing the synergistic effect of cataract surgery and DEX-i one month earlier in eyes with DME, we compared Epiretinal Membrane/Inner Limiting Membrane (ERM/ILM) peeling preceded by DEX-i one month before versus ERM/ILM peeling alone for the treatment of tDME. A retrospective study on patients affected by tDME who underwent ERM/ILM peeling one month after DEX-i (n = 11; Group A) or ERM/ILM peeling alone (n = 10; Group B) was performed. Longitudinal comparison of best-correct visual acuity (BCVA), central retinal thickness (CRT), and intraocular pressure (IOP) between the time of surgery (T0) and each time point (months 1,3,5,6) within and among the groups were assessed. To evaluate the repeated measurements of BCVA, CRT, and IOP, a linear mixed-effects model was used. In Group A, DEX-i significantly improved mean BCVA and CRT (P < 0.001) just after 1 month (T0). After ERM/ILM peeling, mean BCVA and CRT significantly improved from month 1 in Group A and month 3 in Group B. Mixed model revealed a significant difference in BCVA (P ≤ 0.0001) and CRT (P ≤ 0.02) at different time-points among the groups with better results in Group A. Neither complications nor uncontrolled IOP increase was detected. ERM/ILM peeling confirmed its effectiveness in treating tDME. DEX-i performed one month before surgery seemed to be a safe approach and ensured a greater and faster recovery considering functional and tomographic parameters.
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Affiliation(s)
- Francesco Pignatelli
- Eye Clinic, Hospital "SS. Annunziata", ASL TA, Via F. Bruno, 1, 74010, Taranto, Italy
| | - Alfredo Niro
- Eye Clinic, Hospital "SS. Annunziata", ASL TA, Via F. Bruno, 1, 74010, Taranto, Italy.
| | - Matteo Fallico
- Department of Ophthalmology, University of Catania, Catania, Italy
| | - Fedele Passidomo
- Eye Clinic, Hospital "SS. Annunziata", ASL TA, Via F. Bruno, 1, 74010, Taranto, Italy
| | - Samuele Gigliola
- Eye Clinic, Hospital "SS. Annunziata", ASL TA, Via F. Bruno, 1, 74010, Taranto, Italy
| | - Annalisa Nacucchi
- Eye Clinic, Hospital "SS. Annunziata", ASL TA, Via F. Bruno, 1, 74010, Taranto, Italy
| | - Vincenza Bonfiglio
- Department of Experimental Biomedicine and Clinical Neuroscience, University of Palermo, 90127, Palermo, Italy
| | - Michele Reibaldi
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy
| | - Giuseppe Addabbo
- Eye Clinic, Hospital "SS. Annunziata", ASL TA, Via F. Bruno, 1, 74010, Taranto, Italy
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17
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Lin TY, Hsieh YT, Garg SJ, Chen LJ, Chen KJ, Wu WC, Lai CC, Hwang YS, Kang EYC. Systemic Outcomes of Intravitreal Injections of Dexamethasone and Anti-Vascular Endothelial Growth Factor. Ophthalmol Ther 2023; 12:1127-1140. [PMID: 36729247 PMCID: PMC10011242 DOI: 10.1007/s40123-023-00659-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2022] [Accepted: 01/18/2023] [Indexed: 02/03/2023] Open
Abstract
INTRODUCTION Intravitreal dexamethasone and anti-vascular endothelial growth factor (anti-VEGF) medications have revolutionized ocular disease management and favorable ocular safety profiles, but few studies have compared their systemic adverse events (SAEs). This study investigated the SAEs of intravitreal dexamethasone and anti-VEGFs by using real-world data. METHODS This retrospective cohort study sourced medical records from the largest multi-institutional database in Taiwan. Patients who received intravitreal dexamethasone (n = 137) or anti-VEGFs (n = 10,345) between 2014 and 2019 were enrolled. Propensity score matching was performed to achieve homogeneity between the two groups. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (CIs) were calculated using the Fine-Gray model. Systemic as well as ocular clinical events and systemic biomarkers after 1-year follow-up were compared. RESULTS Both groups demonstrated comparable risks of major cardiac adverse events (SHR 1.57, 95% CI 0.29-8.55), heart failure (SHR 0.62, 95% CI 0.07-5.33), major bleeding (SHR 0.23, 95% CI 0.03-1.77), all-cause admission (SHR 0.73, 95% CI 0.41-1.30), and all-cause death (SHR 2.11, 95% CI 0.35-12.71). There were no significant differences in longitudinal changes in systolic and diastolic blood pressure, glycated hemoglobin, low-density lipoprotein, estimated glomerular filtration rate, or alanine aminotransferase between the groups. Both groups had a similar incidence of cataract surgery. Although the dexamethasone group exhibited a relatively high prevalence of antiglaucomatous medication use, there was not a significantly higher incidence of glaucoma surgery. CONCLUSION Intravitreal dexamethasone and anti-VEGF medications had comparable systemic safety profiles in our study. Both drugs represent efficacious and safe therapies for ocular diseases.
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Affiliation(s)
- Tzu-Yi Lin
- Department of Education, Linkou Medical Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.,College of Medicine, Chang Gung University, Taoyuan, Taiwan
| | - Yi-Ting Hsieh
- Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan
| | - Sunir J Garg
- MidAtlantic Retina, The Retina Service of Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
| | - Lee-Jen Chen
- Department of Ophthalmology, Mackay Memorial Hospital, Taipei, Taiwan
| | - Kuan-Jen Chen
- College of Medicine, Chang Gung University, Taoyuan, Taiwan.,Department of Ophthalmology, Linkou Medical Center, Chang Gung Memorial Hospital, No. 5, Fu Shin St., Kuei-Shan, Taoyuan, 333, Taiwan
| | - Wei-Chi Wu
- College of Medicine, Chang Gung University, Taoyuan, Taiwan.,Department of Ophthalmology, Linkou Medical Center, Chang Gung Memorial Hospital, No. 5, Fu Shin St., Kuei-Shan, Taoyuan, 333, Taiwan
| | - Chi-Chun Lai
- College of Medicine, Chang Gung University, Taoyuan, Taiwan.,Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan
| | - Yih-Shiou Hwang
- College of Medicine, Chang Gung University, Taoyuan, Taiwan. .,Department of Ophthalmology, Linkou Medical Center, Chang Gung Memorial Hospital, No. 5, Fu Shin St., Kuei-Shan, Taoyuan, 333, Taiwan. .,Department of Ophthalmology, Jen-Ai Hospital Dali Branch, Taichung, Taiwan. .,Department of Ophthalmology, Xiamen Chang Gung Memorial Hospital, Xiamen, China.
| | - Eugene Yu-Chuan Kang
- College of Medicine, Chang Gung University, Taoyuan, Taiwan. .,Department of Ophthalmology, Linkou Medical Center, Chang Gung Memorial Hospital, No. 5, Fu Shin St., Kuei-Shan, Taoyuan, 333, Taiwan. .,Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
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18
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El Rayes EN, Leila M. Visual function and retinal morphological changes after single suprachoroidal delivery of fluocinolone acetonide (Iluvien®) implant in eyes with chronic diabetic macular edema. Int J Retina Vitreous 2023; 9:20. [PMID: 36991493 PMCID: PMC10053734 DOI: 10.1186/s40942-023-00458-9] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2023] [Accepted: 03/21/2023] [Indexed: 03/31/2023] Open
Abstract
BACKGROUND To assess the efficacy and safety of supra-choroidal (SC) Iluvien in the management of chronic diabetic macular edema (DME). METHODS A retrospective interventional non-comparative consecutive case series including patients with chronic DME who received an SC Iluvien implant. All patients had persistent central macular thickness (CMT) ≥ 300µ after previous treatment with anti-vascular endothelial growth factor (VEGF) agents or laser photocoagulation. The main outcome measures were improvement of best-corrected visual acuity (BCVA), reduction of CMT, and detection of ocular hypertension/glaucoma or cataract formation. Friedman's two-way ANOVA was used to analyze BCVA, intraocular pressure (IOP), and DME across different time points. P-value = 0.05. RESULTS The study included 12 eyes of 12 patients. Six patients (50%) were males. The median age was 58 years (range 52-76 years). The median duration of DM was 13 years (range 8-20 years). Ten patients (83.3%) were phakic and 2 patients (17%) were pseudophakic. The median pre-operative BCVA was 0.07 (range 0.05-0.8). The median pre-operative CMT was 544µ (range 354-745µ). The median pre-operative IOP was 17 mmHg (range 14-21mmHg). The median follow-up period was 12 months, range (12-42). Post-operatively, the median final BCVA was 0.15 (range 0.03-1), p 0.02, the median CMT was 404µ (range 213-747), p 0.4 and the median IOP was 19.5 mmHg (range 15-22), p 1. Two out of 10 phakic patients (20%) developed nuclear sclerosis grade I by 12 months. Six patients (50%) developed a transient rise in IOP < 10 mmHg from the baseline that resolved within 3 weeks with antiglaucoma drops. CONCLUSION SC Iluvien is potentially effective in improving visual function, reducing macular edema, and reducing the incidence of steroid-induced cataracts and glaucoma.
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Affiliation(s)
- Ehab N El Rayes
- Retina department, Research Institute of Ophthalmology (RIO), 35 Salah Salem St., (El Borg), Suite 702, El-Obour bldg., Cairo, 11371, Egypt.
| | - Mahmoud Leila
- Retina department, Research Institute of Ophthalmology (RIO), 35 Salah Salem St., (El Borg), Suite 702, El-Obour bldg., Cairo, 11371, Egypt
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Veiga Reis F, Dalgalarrondo P, da Silva Tavares Neto JE, Wendeborn Rodrigues M, Scott IU, Jorge R. Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study. Int J Retina Vitreous 2023; 9:13. [PMID: 36869355 PMCID: PMC9985227 DOI: 10.1186/s40942-023-00449-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2023] [Accepted: 02/18/2023] [Indexed: 03/05/2023] Open
Abstract
PURPOSE The aim of this study is to investigate the safety of combined intravitreal injection of dexamethasone aqueous-solution (IVD) and bevacizumab (IVB) in patients with refractory diabetic macular edema (DME) and its effect on intraocular pressure (IOP), best-corrected visual acuity (BCVA) and central subfield thickness (CSFT). METHODS This prospective study included 10 patients (10 eyes) with DME refractory to laser photocoagulation and/or anti-vascular endothelial growth factor (anti-VEGF) therapy. A complete ophthalmological examination was performed at baseline, during the first week of treatment, and monthly through week 24. Therapy consisted of monthly injections of combined IVD and IVB "pro re nata" (PRN) if CST > 300 µm. We investigated the impact of the injections on intraocular pressure (IOP), cataract development, Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA), and central sub-foveal thickness (CSFT) measured by spectral-domain optical coherence tomography (OCT). RESULTS Eight patients (80%) completed 24 weeks of follow-up. Compared to baseline, mean IOP increased significantly (p < 0.05) and anti-glaucomatous eye drops were necessary for 50% of the patients, CSFT was significantly reduced at all follow-up visits (p < 0.05), although mean BCVA showed no significant improvement. One patient developed dense cataract progression and another showed vitreoretinal traction at week 24. No inflammation or endophthalmitis was observed. CONCLUSION Treatment of DME refractory to laser and/or anti-VEGF therapy with combined PRN IV dexamethasone aqueous solution and bevacizumab was associated with adverse effects related to the use of corticosteroids. However, there was a significant improvement in CSFT meantime best-correct visual acuity remained stable or improved in 50% of patients.
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Affiliation(s)
- Francyne Veiga Reis
- Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil.
| | - Pedro Dalgalarrondo
- Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil
| | - José Edisio da Silva Tavares Neto
- Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil
| | - Murilo Wendeborn Rodrigues
- Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil
| | - Ingrid U Scott
- Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA
| | - Rodrigo Jorge
- Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil.
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20
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Yuen YS, Gilhotra JS, Dalton M, Aujla JS, Mehta H, Wickremasinghe S, Uppal G, Arnold J, Chen F, Chang A, Fraser-Bell S, Lim L, Shah J, Bowditch E, Broadhead GK. Diabetic Macular Oedema Guidelines: An Australian Perspective. J Ophthalmol 2023; 2023:6329819. [PMID: 36824442 PMCID: PMC9943607 DOI: 10.1155/2023/6329819] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2022] [Revised: 12/21/2022] [Accepted: 12/30/2022] [Indexed: 02/16/2023] Open
Abstract
The number of people living with diabetes is expected to rise to 578 million by 2030 and to 700 million by 2045, exacting a severe socioeconomic burden on healthcare systems around the globe. This is also reflected in the increasing numbers of people with ocular complications of diabetes (namely, diabetic macular oedema (DMO) and diabetic retinopathy (DR)). In one study examining the global prevalence of DR, 35% of people with diabetes had some form of DR, 7% had PDR, 7% had DMO, and 10% were affected by these vision-threatening stages. In many regions of the world (Australia included), DR is one of the top three leading causes of vision loss amongst working age adults (20-74 years). In the management of DMO, the landmark ETDRS study demonstrated that moderate visual loss, defined as doubling of the visual angle, can be reduced by 50% or more by focal/grid laser photocoagulation. However, over the last 20 years, antivascular endothelial growth factor (VEGF) and corticosteroid therapies have emerged as alternative options for the management of DMO and provided patients with choices that have higher chances of improving vision than laser alone. In Australia, since the 2008 NHMRC guidelines, there have been significant developments in both the treatment options and treatment schedules for DMO. This working group was therefore assembled to review and address the current management options available in Australia.
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Affiliation(s)
| | | | | | - Jaskirat S. Aujla
- South Australian Institute of Ophthalmology, Adelaide, SA, Australia
| | - Hemal Mehta
- Save Sight Registries, University of Sydney, Sydney, NSW, Australia
- Strathfield Retina Clinic, Sydney, Australia
| | - Sanj Wickremasinghe
- Centre for Eye Research Australia, The Royal Victorian Eye and Ear Hospital, University of Melbourne, Melbourne, Australia
| | - Gurmit Uppal
- Moreton Eye Group, Brisbane, Queensland, Australia
| | | | - Fred Chen
- Centre for Ophthalmology and Visual Sciences (Incorporating Lions Eye Institute), The University of Western Australia, Nedlands, WA, Australia
- Ophthalmology, Department of Surgery, University of Melbourne, Victoria, Australia
| | - Andrew Chang
- Sydney Institute of Vision Science, University of Sydney, Sydney, NSW, Australia
- Sydney Retina Clinic and Day Surgery, University of Sydney, Sydney, NSW, Australia
- Save Sight Institute, University of Sydney, Sydney, NSW, Australia
| | - Samantha Fraser-Bell
- Department of Ophthalmology, Save Sight Institute, University of Sydney, Sydney, NSW, Australia
| | - Lyndell Lim
- Centre for Eye Research Australia, The Royal Victorian Eye and Ear Hospital, University of Melbourne, Melbourne, Australia
| | - Janika Shah
- Sydney Eye Hospital, Sydney, Australia
- Singapore National Eye Centre, Singapore
| | - Ellie Bowditch
- Save Sight Institute, University of Sydney, Sydney, NSW, Australia
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21
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Saraf I, Kushwah V, Alva C, Koutsamanis I, Rattenberger J, Schroettner H, Mayrhofer C, Modhave D, Braun M, Werner B, Zangger K, Paudel A. Influence of PLGA End Groups on the Release Profile of Dexamethasone from Ocular Implants. Mol Pharm 2023; 20:1307-1322. [PMID: 36680524 DOI: 10.1021/acs.molpharmaceut.2c00945] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/22/2023]
Abstract
The present study deals with the development of dexamethasone (DM)-loaded implants using ester end-capped Resomer RG 502 poly(lactic acid-co-glycolic acid) (PLGA) (502), acid end-capped Resomer RG 502H PLGA (502H), and a 502H:502 mixture (3:1) via hot melt extrusion (HME). The prepared intravitreal implants (20 and 40% DM loaded in each PLGA) were thoroughly investigated to determine the effect of different end-capped PLGA and drug loading on the long-term release profile of DM. The implants were characterized for solid-state active pharmaceutical ingredient (APIs) using DSC and SWAXS, water uptake during stability study, the crystal size of API in the implant matrix using hot-stage polarized light microscopy, and in vitro release profile. The kinetics of PLGA release was thoroughly investigated using quantitative 1H NMR spectroscopy. The polymorph of DM crystal was found to remain unchanged after the extrusion and stability study. However, around 3 times reduction in API particle size was observed after the HME process. The morphology and content uniformity of the RT-stored samples were found to be comparable to the initial implant samples. Interestingly, the samples (mainly 502H) stored at 40 °C and 75% RH for 30 d demonstrated marked deformation and a change in content uniformity. The rate of DM release was higher in the case of 502H samples with a higher drug loading (40% w/w). Furthermore, a simple digital in vitro DM release profile derived for the formulation containing a 3:1 ratio of 502H and 502 was comparable with the experimental release profile of the respective polymer mixture formulation. The temporal development of pores and/or voids in the course of drug dissolution, evaluated using μCT, was found to be a precursor for the PLGA release. Overall, the release profile of DM was found to be dependent on the PLGA type (independent of subtle changes in the formulation mass and diameter). However, the extent of release was found to be dependent on DM loading. Thus, the present investigation led to a thorough understanding of the physicochemical properties of different end-capped PLGAs and the underlying formulation microstructure on the release profile of a crystalline water-insoluble drug, DM, from the PLGA-based implant.
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Affiliation(s)
- Isha Saraf
- Research Centre for Pharmaceutical Engineering, Inffeldgasse 13/2, Graz8010, Austria
| | - Varun Kushwah
- Research Centre for Pharmaceutical Engineering, Inffeldgasse 13/2, Graz8010, Austria
| | - Carolina Alva
- Research Centre for Pharmaceutical Engineering, Inffeldgasse 13/2, Graz8010, Austria
| | - Ioannis Koutsamanis
- Research Centre for Pharmaceutical Engineering, Inffeldgasse 13/2, Graz8010, Austria
| | | | - Hartmuth Schroettner
- Graz Centre for Electron Microscopy (ZFE), Steyrergasse 17, Graz8010, Austria.,Institute of Electron Microscopy and Nanoanalysis (FELMI), NAWI Graz, Graz University of Technology, Steyrergasse 17, Graz8010, Austria
| | - Claudia Mayrhofer
- Graz Centre for Electron Microscopy (ZFE), Steyrergasse 17, Graz8010, Austria
| | - Dattatray Modhave
- Research Centre for Pharmaceutical Engineering, Inffeldgasse 13/2, Graz8010, Austria
| | - Michael Braun
- Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach88397, Germany
| | - Bernd Werner
- Institute of Chemistry, University of Graz, Heinrichstr. 28, Graz8010, Austria
| | - Klaus Zangger
- Institute of Chemistry, University of Graz, Heinrichstr. 28, Graz8010, Austria
| | - Amrit Paudel
- Research Centre for Pharmaceutical Engineering, Inffeldgasse 13/2, Graz8010, Austria.,Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13/3, Graz8010, Austria
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Iglicki M, Busch C, Lanzetta P, Sarao V, Veritti D, Rassu N, Lupidi M, Cebeci Z, Fraser-Bell S, Bernal-Morales C, Sala-Puigdollers A, Zarranz-Ventura J, Gallego-Pinazo R, Maiti A, D'Amico Ricci G, Udaondo P, Loewenstein A, Chhablani J, Zur D. Vitrectomized vs non-vitrectomized eyes in DEX implant treatment for DMO-Is there any difference? the VITDEX study. Eye (Lond) 2023; 37:280-284. [PMID: 35043004 PMCID: PMC9873723 DOI: 10.1038/s41433-022-01931-9] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2021] [Revised: 01/07/2022] [Accepted: 01/10/2022] [Indexed: 01/28/2023] Open
Abstract
OBJECTIVE We aimed to compare visual and anatomical outcome in vitrectomized and non-vitrectomized eyes treated with dexamethasone (DEX) implant due to diabetic macular oedema (DMO). DESIGN Multicenter, retrospective, interventional study. PARTICIPANTS 236 eyes from 234 patients with DMO with or without previous vitrectomy performed with follow-up of 12 months. METHODS Records were reviewed for cases of DMO treated with DEX implant in vitrectomized and not vitrectomized eyes. Best corrected visual acuity (BCVA), central subfoveal thickness (CST), and intraocular pressure (IOP) were recorded at baseline and 12 months after treatment with DEX implants. Correlations between vitreous status and visual and anatomical outcome, as well as safety profile were analysed. MAIN OUTCOME MEASURES BCVA and CST over follow-up period. SECONDARY OUTCOMES cataract rate formation, intraocular pressure increase, number of implants needed. RESULTS The non-vitrectomized group included 130 eyes (55.1%), the vitrectomized group included 106 eyes (44.9%). The groups were well balanced for age and gender (p = 0.540, and p = 0.053, respectively). Both groups showed statistically significant improvement in BCVA and CST (for all groups: p < 0.001). There was no significant difference between the groups in terms of change in vision (p = 0.89) and anatomy (p = 0.65). The mean number of DEX implants given during follow-up was 3.5 in both groups, and there was no significant difference between the groups (p = 0.81). CONCLUSION We demonstrated similar anatomical and functional efficacy of DEX implant in non-vitrectomized and vitrectomized eyes. Its efficacy was not influenced by full vitrectomy for diabetic retinopathy complications. Safety profile was well balanced between groups.
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Affiliation(s)
- Matias Iglicki
- Private Retina Office, University of Buenos Aires, Buenos Aires, Argentina.
| | - Catharina Busch
- Department of Ophthalmology, University of Leipzig, Leipzig, Germany
| | - Paolo Lanzetta
- Department of Medicine-Ophthalmology, University of Udine, Piazzale S. Maria della Misericordia, 33100, Udine, Italy
| | - Valentina Sarao
- Department of Medicine-Ophthalmology, University of Udine, Piazzale S. Maria della Misericordia, 33100, Udine, Italy
| | - Daniele Veritti
- Department of Medicine-Ophthalmology, University of Udine, Piazzale S. Maria della Misericordia, 33100, Udine, Italy
| | - Nicolò Rassu
- Department of Medicine-Ophthalmology, University of Udine, Piazzale S. Maria della Misericordia, 33100, Udine, Italy
| | - Marco Lupidi
- Department of Medicine and Surgery, Section of Ophthalmology, University of Perugia, S. Maria della Misericordia Hospital, 06156, Perugia, Italy
- Fondazione per la Macula Onlus, Di.N.O.G.Mi., University Eye Clinic, Viale Benedetto XV, 16132, Genova, Italy
- Centre de l'Odéon, 113 Boulevard St Germain, 75006, Paris, France
| | - Zafer Cebeci
- Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
| | - Samantha Fraser-Bell
- Department of Ophthalmology, Save Sight Institute, University of Sydney, Sydney, NSW, Australia
| | | | | | | | | | - Aniruddha Maiti
- Susrut Eye Foundation & Research Centre Kolkata, Kolkata, India
| | | | | | - Anat Loewenstein
- Division of Ophthalmology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Jay Chhablani
- University of Pittsburgh, UPMC Eye Center, Pittsburgh, PA, USA
| | - Dinah Zur
- Division of Ophthalmology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
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İlgüy S, Işık MU. Prognostic value of choroidal vascular index in determining response to intravitreal dexamethasone implant treatment used in refractory diabetic macular edema. Lasers Med Sci 2023; 38:47. [PMID: 36680633 DOI: 10.1007/s10103-023-03711-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2022] [Accepted: 01/11/2023] [Indexed: 01/22/2023]
Abstract
To investigate the effect of intravitreal dexamethasone (IVD) implant injection, which was used in the treatment of DME, on CVI and to investigate whether CVI can be used as a prognostic marker in the treatment of anti-VEGF resistant DME. A retrospective observational and comparative study. Twenty-five eyes of 25 patients with refractory diabetic macular edema who underwent intravitreal dexamethasone (IVD) implant and 50 eyes of 50 healthy patients were included in the study. Central macular thickness (CMT), subfoveal choroidal thickness (SFCT), luminal choroidal area (LCA), total choroidal area (TCA), stromal choroidal area (SCA), and choroidal vascularity index (CVI) were measured on optical coherence tomography. There was no significant difference between the groups in terms of age and gender. When the pre-treatment values in the IVD group were compared with the healthy group, LCA and SCA values were higher, and CVI ratios were lower in the IVD group compared to the control group. When baseline, 1st, and 3rd months after injection were compared, it was determined that there was a significant decrease in CMT and LCA. There was no statistically significant difference in SFCT, TCA, and CVI. There was a significant negative correlation between baseline CVI and 3rd month CMT after IVD (rho: - 0.643, p: 0.001). It was observed that the baseline and 1st month LCA values were significantly higher than the 3rd month. The choroidal vascular structure may be affected by IVD treatment. CVI may also have value as a prognostic marker in monitoring the response to treatment.
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Affiliation(s)
- Serdar İlgüy
- Retina Department, Department of Ophthalmology, Kastamonu Training and Research Hospital, Kastamonu, Turkey.
| | - Mehmed Uğur Işık
- Retina Department, Department of Ophthalmology, Faculty of Medicine, Kastamonu University, Kastamonu, Turkey
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24
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Studnička J, Němčanský J, Vysloužilová D, Ernest J, Němec P. Diabetic Retinopathy – Diagnostics and Treatment Guidelines. CESKA A SLOVENSKA OFTALMOLOGIE : CASOPIS CESKE OFTALMOLOGICKE SPOLECNOSTI A SLOVENSKE OFTALMOLOGICKE SPOLECNOSTI 2023; 79:238-247. [PMID: 37993272 DOI: 10.31348/2023/28] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/24/2023]
Abstract
Diabetic retinopathy is one of the most common complications of diabetes mellitus and represents a serious health, social and economic problem. With the expected increase in the number of patients with diabetes, it is becoming the leading cause of severe vision loss in the working-age population. The presented guidelines summarize the current knowledge about this disease in order to standardize and update the procedures for the diagnosis, classification and treatment of diabetic retinopathy.
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25
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Chan LKY, Lin SS, Chan F, Ng DSC. Optimizing treatment for diabetic macular edema during cataract surgery. Front Endocrinol (Lausanne) 2023; 14:1106706. [PMID: 36761187 PMCID: PMC9905225 DOI: 10.3389/fendo.2023.1106706] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2022] [Accepted: 01/09/2023] [Indexed: 01/26/2023] Open
Abstract
Diabetic macular edema (DME) causes visual impairment in diabetic retinopathy (DR). Diabetes mellitus is a global epidemic and diabetic individuals are at risk of developing DR. Approximately 1 in 10 diabetic patients suffers from DME, which is the commonest cause of vision-threatening DR at primary-care screening. Furthermore, diabetes predisposes to a higher frequency and a younger onset of cataract, which further threatens vision in DME patients. Although cataract extraction is an effective cure, vision may still deteriorate following cataract surgery due to DME progression or recurrence, of which the risks are significantly higher than for patients without concurrent or previous history of DME at the time of operation. The management of pre-existing DME with visually significant cataract is a clinical conundrum. Deferring cataract surgery until DME is adequately treated is not ideal because of prolonged visual impairment and maturation of cataract jeopardizing surgical safety and monitoring of DR. On the other hand, the progression or recurrence of DME following prompt cataract surgery is a profound disappointment for patients and ophthalmic surgeons who had high expectations for postoperative visual improvement. Prescription of perioperative anti-inflammatory eye drops is effective in lowering the risk of new-onset DME after cataract surgery. However, management of concurrent DME at the time of cataract surgery is much more challenging because DME is unlikely to resolve spontaneously even with the aid of anti-inflammatory non-steroidal or steroid eye drops. A number of clinical trials using intravitreal injection of corticosteroids and anti-vascular endothelial growth factor (anti-VEGF) as first-line therapy have demonstrated safety and efficacy to treat DME. These drugs have also been administered perioperatively for the prevention of DME worsening in patients undergoing cataract surgery. This article reviews the scientific evidence to guide ophthalmologists on the efficacy and safety of various therapies for managing patients with DME who are particularly vulnerable to cataract surgery-induced inflammation, which disintegrates the blood-retinal barrier and egression of fluid in macular edema.
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Affiliation(s)
- Leo Ka Yu Chan
- Hong Kong Eye Hospital, Hong Kong, Hong Kong SAR, China
- Department of Ophthalmology and Visual Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China
| | - Sui Sum Lin
- Department of Ophthalmology and Visual Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China
- Department of Counselling and Psychology, Faculty of Social Sciences, Hong Kong Shue Yan University, Hong Kong, Hong Kong SAR, China
| | - Fiona Chan
- Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China
| | - Danny Siu-Chun Ng
- Hong Kong Eye Hospital, Hong Kong, Hong Kong SAR, China
- Department of Ophthalmology and Visual Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China
- *Correspondence: Danny Siu-Chun Ng,
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26
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Wakabayashi T, Liu CK, Anderson HE, Mahmoudzadeh R, Nguyen MK, Salabati M, Chiang A, Hsu J, Garg SJ, Spirn MJ. A Comparison of Ocular Complications after 0.7 mg Dexamethasone Implant versus 2 mg of Intravitreal Triamcinolone in Vitrectomized Eyes. Ophthalmol Retina 2022:S2468-6530(22)00624-8. [PMID: 36572383 DOI: 10.1016/j.oret.2022.12.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2022] [Revised: 12/14/2022] [Accepted: 12/19/2022] [Indexed: 12/24/2022]
Abstract
OBJECTIVE To compare the rates of complications in eyes that received a dexamethasone (DEX) implant (0.7 mg) or intravitreal triamcinolone (IVT) (2 mg) to treat postvitrectomy macular edema (ME). DESIGN Retrospective, comparative, case series. SUBJECTS A total of 148 eyes (147 patients); 75 eyes (75 patients) in the DEX group and 73 eyes (72 patients) in the IVT group. METHODS The medical records of patients who received an intravitreal DEX 0.7 mg (Ozurdex) or triamcinolone (2 mg) (Triesence) for postvitrectomy ME between July 2014 and December 2021 with a minimum follow-up of 3 months were reviewed. Ocular hypotony and ocular hypertension were defined as intraocular pressure of < 6 mmHg and > 24 mmHg, respectively. MAIN OUTCOME MEASURES The rates of complications. RESULTS The follow-up duration was 2.5 ± 1.6 years, with no significant difference between the groups (P = 0.398). The rate of transient ocular hypotony per eye and per injection was significantly higher in the DEX group (10 eyes [13%], 30 of 443 injections [7%]) compared with the IVT group (2 eyes [3%], 2 of 262 injections [0.8%]) (P = 0.039 and < 0.001, respectively). Mean visual acuity significantly decreased at the time of ocular hypotony (P = 0.031), but returned to preinjection level after resolution of the hypotony after a median of 12 days. The incidence of ocular hypertension was higher in the DEX group (23 eyes [31%]) than the IVT group (16 eyes [22%]), but this was not statistically significant (P = 0.307). Ocular hypertension was controlled with observation or topical medication. There were no between-group differences in the incidence of vitreous hemorrhage (DEX, 3 eyes [4%]; IVT, 1 eye [1%]; P = 0.632) or rhegmatogenous retinal detachment (DEX, 3 eyes [4%]; IVT, 0 eyes [0%]; P = 0.253). Four eyes (5%) experienced migration of the DEX implant into the anterior chamber. No eye developed endophthalmitis. CONCLUSION The incidence of ocular hypotony, which causes transient visual impairment, was significantly higher in vitrectomized eyes treated with DEX compared with eyes treated with IVT. Injections other than the inferotemporal quadrant or rotating injection sites may be recommended. FINANCIAL DISCLOSURE(S) Proprietary or commercial disclosure may be found after the references.
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Affiliation(s)
- Taku Wakabayashi
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Catherine K Liu
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Hannah E Anderson
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Raziyeh Mahmoudzadeh
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Michael K Nguyen
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Mirataollah Salabati
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Allen Chiang
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Jason Hsu
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Sunir J Garg
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania
| | - Marc J Spirn
- Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania.
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Yuan Q, Liu Y, Gou Y, Xu H, Gao Y, Liu Y, Chen Y, Zhang M. Efficacy and safety of the dexamethasone implant in vitrectomized and nonvitrectomized eyes with diabetic macular edema: A systematic review and meta-analysis. Front Pharmacol 2022; 13:1029584. [DOI: 10.3389/fphar.2022.1029584] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2022] [Accepted: 11/21/2022] [Indexed: 12/04/2022] Open
Abstract
Purpose: To compare the efficacy and safety of the intravitreal dexamethasone (DEX) implant for the treatment of diabetic macular edema (DME) in vitrectomized and nonvitrectomized eyes.Methods: We performed a literature search in four electronic databases (PubMed, EMBASE, MEDLINE, and Cochrane Library) from inception to 22 May 2022. Studies comparing the efficacy of the DEX implant in vitrectomized and nonvitrectomized eyes with DME with at least 3 months of follow-up were included. The main outcomes included comparison of the mean change in the best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to different follow-up endpoints between the vitrectomized and nonvitrectomized groups. The secondary outcomes were the mean duration of action for the first DEX implantation and the number of required injections throughout the follow-up period. Safety data were collected and compared.Results: The final analysis included 7 studies involving 582 eyes, 208 vitrectomized eyes and 374 nonvitrectomized eyes. The mean between-group differences in BCVA improvement were not significant at any endpoint, with averages difference of −0.07 logarithm of the minimum angle of resolution (logMAR) (p = 0.088) at 1 month, −0.03 logMAR (p = 0.472) 3 months, −0.07 logMAR (p = 0.066) 6 months, and −0.04 logMAR (p = 0.486) 12 months. The mean between-group differences in CMT reduction were not statistically significant, with mean differences of 7.17 μm (p = 0.685) at 1 month, 20.03 μm (p = 0.632) 3 months, −1.80 μm (p = 0.935) 6 months, and −25.65 μm (p = 0.542) 12 months. However, the vitrectomized group had a significantly shorter duration of action during the first DEX implantation than the nonvitrectomized group, with a mean difference of 0.8 months (p = 0.005). No significant between-group differences were detected for the number of required injections or safety profile.Conclusion: This meta-analysis showed similar efficacy and safety of the sustained-release DEX intravitreal implant for vitrectomized and nonvitrectomized eyes with DME. The intravitreal DEX implant could be considered an effective choice for DME treatment in eyes with prior vitrectomy.
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28
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Kim K, Kim ES, Kim DG, Yu SY. The effect of intravitreal dexamethasone implantation on diabetic macular edema refractory to anti-vascular endothelial growth factor treatment. EXPERT REVIEW OF OPHTHALMOLOGY 2022. [DOI: 10.1080/17469899.2022.2118715] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]
Affiliation(s)
- Kiyoung Kim
- Department of Ophthalmology, Kyung Hee University Hospital, Kyung Hee University, Seoul, South Korea
| | - Eung Suk Kim
- Department of Ophthalmology, Kyung Hee University Hospital, Kyung Hee University, Seoul, South Korea
| | - Do Gyun Kim
- Department of Ophthalmology, Myongji Hospital, Hanyang University Medical Center, Goyang-si, South Korea
| | - Seung-Young Yu
- Department of Ophthalmology, Kyung Hee University Hospital, Kyung Hee University, Seoul, South Korea
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Liang Y, Yan B, Xie M, Meng Z, Ma J, Ma B, Luo J. One-Month Outcomes of Intravitreal Anti-VEGF vs. Dexamethasone Implant in the Treatment of Diabetic Macular Edema in Vitrectomized Eyes. Front Med (Lausanne) 2022; 9:895220. [PMID: 35774995 PMCID: PMC9237330 DOI: 10.3389/fmed.2022.895220] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2022] [Accepted: 05/20/2022] [Indexed: 11/26/2022] Open
Abstract
Objectives To compare short-term effect of intravitreal ranibizumab with dexamethasone implant for diabetic macular edema (DME) in vitrectomized eyes. Methods Single-center, prospective, randomized study of vitrectomized eyes with DME. Study eyes were divided into two groups, receiving ranibizumab (IVV group, n = 35 eyes) or dexamethasone implant (IVD group, n = 35 eyes) respectively. Patients were evaluated at baseline, Week 1 and Month 1. The main outcome measures included best-corrected visual acuity (BCVA), central retinal thickness (CRT) and intraocular pressure (IOP). Results BCVA and CRT were similar in the two groups at baseline. At Week 1, the CRT improvement was significant in two groups (P = 0.041 in IVV group, P = 0.030 in IVD group), but at Month 1, only IVD group had significant improvement in CRT (P < 0.001). And BCVA gains were significant at Week 1 (P = 0.029) and Month 1 (P = 0.001) in IVD group, whereas IVV group did not show significant BCVA gains (P = 0.056 at Week1, P = 0.166 at Month 1). The changes of BCVA and CRT were significantly higher in IVD group than IVV group at Month1, but the changes were not significant at Week1. Conclusions Comparing to anti-VEGF therapy, DEX implant is more effect in improving BCVA and reducing CRT in vitrectomized eyes at 1 month, which indicated DEX implant is a better strategy.
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30
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Marashi A, Zazo A. Suprachoroidal injection of triamcinolone acetonide using a custom-made needle to treat diabetic macular edema post pars plana vitrectomy: a case series. J Int Med Res 2022; 50:3000605221089807. [PMID: 35414288 PMCID: PMC9019375 DOI: 10.1177/03000605221089807] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Objective Diabetic macular edema (DME), the most common cause of diabetes-related visual impairment, may occur following pars plana vitrectomy (PPV) to manage proliferative diabetic retinopathy complications. This retrospective single-centre case series evaluated the efficacy and safety of injecting 4 mg/0.1 ml triamcinolone into the suprachoroidal space using a custom-made needle to treat DME post PPV. Methods Data regarding central macular thickness (CMT) using spectral domain-optical coherence tomography and best-corrected visual acuity (by Snellen chart) at baseline (pre-injection), and at 1, 4, and 8 weeks following injection were analysed, along with intraocular pressure (IOP), cataract progression, and ocular safety. Results Eleven eyes in 10 patients received 11 suprachoroidal injections. Vision improvement was noted (0.75 log minimum angle of resolution (MAR) at baseline to 0.40 log MAR after treatment). CMT reduced significantly from 456.45 ± 113.42 μm at baseline to 247.63 ± 53.40 μm at 8 weeks following injection. No rise in IOP, or cataract development in the single treated phakic eye, was observed during 8 weeks of follow-up. Conclusion Suprachoroidal injection of triamcinolone using a custom-made needle to treat DME post PPV shows promising results with acceptable safety outcomes. Large clinical trials with longer follow-up are needed to evaluate this treatment option for countries with limited health-care resources.
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Affiliation(s)
| | - Aya Zazo
- Faculty of Medicine, University of Aleppo, Aleppo, Syria
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Kwon JW, Park YG. CLINICAL FEATURES OF INTRAVITREAL DEXAMETHASONE IMPLANTATION IN VITRECTOMIZED EYES OF PATIENTS WITH DIABETIC MACULAR EDEMA. Retina 2022; 42:782-788. [PMID: 34907121 DOI: 10.1097/iae.0000000000003380] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
PURPOSE To identify the clinical outcomes of intravitreal dexamethasone implantation (IVD) in previously vitrectomized eyes of patients with diabetic macular edema. METHOD We performed a retrospective observational study. We recorded central subfield thickness, best-corrected visual acuity, and intraocular pressure up to 12 months after IVD implant placement. We compared the duration of IVD action, intraocular pressure trends, and the prevalence of ocular hypertension after the first IVD treatment of nonvitrectomized and vitrectomized eyes. We also compared the central subfield thickness, best-corrected visual acuity, number of IVD treatments, and prevalence of ocular hypertension between the 2 groups after 12 months. RESULTS We found no significant between-group differences in the central subfield thickness, best-corrected visual acuity, or the prevalence of ocular hypertension during treatment. However, the duration of action of the first IVD treatment was significantly shorter in vitrectomized eyes, and these eyes required more IVD treatments during the 12-month follow-up period. The maximal average intraocular pressure was observed at 2 months after the first IVD treatment in the nonvitrectomized group, but 1 month after the first IVD treatment in the vitrectomized group. CONCLUSION These findings suggest that the IVD pharmacokinetics and pharmacodynamics differ between vitrectomized and nonvitrectomized eyes. Nevertheless, given the relatively long-lasting effectiveness of the treatment and the good clinical results, consecutive IVD treatments may be beneficial for patients with diabetic macular edema with previously vitrectomized eyes.
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Affiliation(s)
- Jin-Woo Kwon
- Department of Ophthalmology, St. Vincent's Hospital, College of Medicine, the Catholic University of Korea, Seoul, Korea; and
| | - Young-Gun Park
- Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Korea
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Kishore K, Bhat PV, Venkatesh P, Canizela CC. Dexamethasone Intravitreal Implant for the Treatment of Macular Edema and Uveitis: A Comprehensive Narrative Review. Clin Ophthalmol 2022; 16:1019-1045. [PMID: 35418744 PMCID: PMC8995179 DOI: 10.2147/opth.s209395] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2021] [Accepted: 03/10/2022] [Indexed: 01/09/2023] Open
Abstract
Purpose The purpose of this review article is to provide a comprehensive review of the current applications of intravitreal DEX implant (Ozurdex®, Allergan Inc, Irvine, CA) for a variety of ophthalmic conditions – ranging from FDA approved indications to off-label uses. We have attempted to provide relevant evidence from the literature to help a reader develop an understanding of the biological and pharmacokinetic properties of DEX implant, its uses, and potential side effects. Methods PubMed searches were performed using the terms “Ozurdex”, or “intravitreal DEX implant”, AND “retinal vein occlusion”, or “diabetic macular edema”, or “uveitis”. The search was performed in July of 2021, with an additional search in October 2021. All original English language articles were considered for this review. Results DEX implant has evidence of efficacy in a variety of clinical situations including macular edema associated with retinal vein occlusion, diabetes, uveitis, and others. Safety concerns include cataract formation and progression, intraocular pressure elevation, complications related to intravitreal injection, and opportunistic infections secondary to steroid-induced immune suppression. Conclusion DEX implant is a useful tool in the management of several retinal disorders. Further studies are needed for head-to-head comparison with other treatment modalities and to determine its precise place in clinical practice.
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Affiliation(s)
- Kamal Kishore
- Illinois Retina and Eye Associates, Peoria, IL, USA
- Department of Surgery, University of Illinois College of Medicine, Peoria, IL, USA
- Correspondence: Kamal Kishore, Illinois Retina and Eye Associates, 4505 N Rockwood Drive, Suite 1, Peoria, IL, 61615, USA, Tel +1 3095891880, Fax +1 3095891885, Email
| | - Pooja V Bhat
- Department of Ophthalmology and Visual Sciences, Illinois Eye and Ear Infirmary, University of Illinois at Chicago, Chicago, IL, 60612, USA
| | - Pradeep Venkatesh
- Department of Ophthalmology, Dr. Rajendra Prasad Center for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi, 110029, India
| | - Cecilia C Canizela
- Department of Surgery, University of Illinois College of Medicine, Peoria, IL, USA
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Lin Y, Ren X, Chen D. Steroid Treatment in Macular Edema: A Bibliometric Study and Visualization Analysis. Front Pharmacol 2022; 13:824790. [PMID: 35273502 PMCID: PMC8902303 DOI: 10.3389/fphar.2022.824790] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2021] [Accepted: 01/17/2022] [Indexed: 02/05/2023] Open
Abstract
The use of steroids to treat macular edema (ME) is a research hotspot in ophthalmology. We utilized CiteSpace and VOSviewer software to evaluate the Web of Science Core Collection publications and to build visualizing maps to describe the research progress in this topic. There were 3,252 publications for three decades during 1988–2021. The number of studies was low during the first 14 years but has risen consistently in the following two decades. The average publications per year were only 4.8 during 1988–2002, which jumped to 113 per year during 2003–2012, and 227 per year during 2013–2021. These publications came from 83 countries/regions, with the United States, Germany, and Italy leading positions. Most studies were published in Investigative Ophthalmology Visual Science, and Ophthalmology was the most cited journal. We found 9,993 authors, with Bandello F having the most publications and Jonas JB being the most frequently co-cited. According to our research, the most popular keyword is triamcinolone acetonide (TA). Macular edema, diabetic macular edema (DME), retinal vein occlusion (RVO), dexamethasone (DEX), fluocinolone acetonide (FA), and some other keywords were commonly studied in this field. In conclusion, the bibliometric analysis provides a comprehensive overview of steroid hotspots and developmental tendencies in the macular edema study. While anti-VEGF therapy is the first-line treatment for DME and RVO-induced macular edema, steroids implant is a valid option for these DME patients not responding to anti-VEGF therapy and non-DME patients with macular edema. Combined therapy with anti-VEGF and steroid agents is vital for future research.
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Affiliation(s)
- Yu Lin
- Research Laboratory of Ophthalmology and Vision Sciences, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.,Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, China
| | - Xiang Ren
- Research Laboratory of Ophthalmology and Vision Sciences, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.,Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, China
| | - Danian Chen
- Research Laboratory of Ophthalmology and Vision Sciences, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.,Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, China
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Sweta VD, Shibi Dev BN, Sandhya R. Secondary glaucoma after intravitreal dexamethasone implant (Ozurdex) injection in patients with retinal disorder: A retrospective study. Indian J Ophthalmol 2022; 70:585-589. [PMID: 35086242 PMCID: PMC9023975 DOI: 10.4103/ijo.ijo_684_21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
Purpose: To investigate the rate of secondary glaucoma after intravitreal (IV) dexamethasone implant (ozurdex) 0.7 mg injection in a retinal disorder over a clinical treatment period of 2 years in a tertiary eye care center. Methods: Retrospective study based on the records of patients receiving IV ozurdex 0.7 mg implant for T/t of cystoid macular edema (CME), diabetic macular edema (DME), macular edema due to central retinal vein occlusion/branch retinal vein occlusion (CRVO/BRVO), and choroidal neovascular membrane (CNVM) at a tertiary eye care hospital for 2 years with 6 months of follow-up. The post-T/t intraocular pressure (IOP) and antiglaucoma medication (AGM) required was recorded at day 1, 1 week, 1, 2, 3, 4, and 6 months and analyzed for secondary IOP spike or ocular hypertension defined as IOP >21 mmHg at any point in time. The patients with pre-existing glaucoma and lost to follow-up were excluded. Results: A total of 102 eyes of 80 patients were included in the study. The mean baseline IOP was 14.40 + 2.97 mmHg, post-injection was 15.01 + 3.22 mmHg at day 1, 15.15 + 3.28 mmHg at 1 week, 15.96 + 3.62 mmHg at 1 month, 16.26 + 3.95 mmHg at 2 months, 15.41 + 3.33 mmHg at 3 months, 15.38 + 3.28 mmHg at 4 months, and 14.27 + 2.69 mmHg at 6 months. No significant difference was seen from baseline IOP at day 1 (P = 0.163), 1 week (P = 0.086), and 6 months (P = 0.748). Statistically significant difference was seen at 1 month (P = 0.0009), 2 months (P = 0.0001), 3 months (P = 0.023), and 4 months (P = 0.026). The mean IOP peak at 2 months recovered to baseline by 6 months subgroup IOP trend shows a similar variation and the results are consistent with the studies in the literature. About 19/102 (18.62%) eyes showed an IOP spike post-T/t. The maximum was seen at 2 months; 16 eyes showed a rise in the range 22–25 mmHg; 8 in the range 26–30 mmHg; and 1 eye had 34 mmHg and required multiple AGM—no surgical intervention was needed. Conclusion: A secondary IOP spike post-IV ozurdex 0.7 mg seen in 18.62% of the cases require AGM. The IOP monitoring should be meticulously performed for the variations and secondary IOP spike management to prevent irreversible damage to the optic nerve and visual field.
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Affiliation(s)
- V D Sweta
- Department of Glaucoma, Nethradhama Superspeciality Eye Hospital, Bangalore, Karnataka, India
| | - B N Shibi Dev
- Department of Glaucoma, Nethradhama Superspeciality Eye Hospital, Bangalore, Karnataka, India
| | - R Sandhya
- Department of Glaucoma, Nethradhama Superspeciality Eye Hospital, Bangalore, Karnataka, India
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Intravitreal dexamethasone: variation of surgical technique and prevention of ocular complications with ASOCT follow-up. Graefes Arch Clin Exp Ophthalmol 2022; 260:2819-2828. [PMID: 35471738 PMCID: PMC9418082 DOI: 10.1007/s00417-022-05650-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2021] [Revised: 03/16/2022] [Accepted: 03/25/2022] [Indexed: 12/05/2022] Open
Abstract
PURPOSE To verify the correct decision-making procedure on performing an intravitreal injection by investigating the in vivo wound morphology and evolution of 22-gauge wounds after dexamethasone oblique injection with anterior segment optical coherence tomography (OCT). DESIGN Prospective, observational consecutive case series. METHODS Subjects underwent a dexamethasone injection at University Eye Clinic of Turin. All the injections have been performed in an oblique (aka beveled or angled) fashion. Patients were divided according to the number of injections already performed with dexamethasone. Group 1 consisted of patients at the first injection, group 2 of patients at a second or more injection always in the same quadrant, and group 3 of patients at the second or more injection in a different quadrant. The incisions were imaged with the Heidelberg SPECTRALIS OCT device on postoperative days 1, 8, and 15. The main outcome measure was wound structure/characteristics (e.g., presence of gaping) as evaluated with OCT. Surgical and ocular parameters were also recorded. RESULTS Thirty-three consecutive patients were investigated. OCT demonstrated closed wounds in all eyes on postoperative days 1, 8, and 15. In all patients, the external (entry) side of the incision was seen as a gape; however, the rest of the wound was closed. No complications were recorded in the different patients during the follow-up. In patients of group 1, we identified the scleral pathway in 10 eyes at day 1. At 8 days in 9 of 10 eyes, the sclera had returned to its restitutio ad integrum. In patients of group 2, the scleral pathway was recognizable on the first day of control; in 7 patients, this was accompanied by the presence of intrascleral edema with peri-wound fluid. At the 8-day checkup, 3 eyes still showed signs attributable to the intrascleral pathway accompanied by peri-wound edema. In group 3, it was possible to identify the intrascleral pathway in 8 patients. There were no signs of intrascleral peri-wound edema or other anatomical changes in 9 patients as early as the first day. In the 8-day follow-up, the signs of scleral edema were absent in the single patient who presented them. At 15 days, there were no signs of scleral pathway in all eyes analyzed. CONCLUSIONS Speaking of intravitreal injections of slow-release dexamethasone, the technique that involves moving the conjunctiva and a beveled or angled sclerotomy after a careful choice of the injection site, paying attention to vary the quadrant involved with each puncture, reduces the number of days of closure of the sclera via and the scleral damage, thus protecting the patient from complications. For the future, it is hoped that the operating microscope and intraoperative OCT will be used on every occasion.
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Pesonen M, Kankaanpää E, Vottonen P. Cost-effectiveness of dexamethasone and triamcinolone for the treatment of diabetic macular oedema in Finland: A Markov-model. Acta Ophthalmol 2021; 99:e1146-e1153. [PMID: 33421332 PMCID: PMC8597173 DOI: 10.1111/aos.14745] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2020] [Revised: 11/23/2020] [Accepted: 11/29/2020] [Indexed: 01/20/2023]
Abstract
PURPOSE Diabetic macular oedema (DMO), a complication of diabetes, causes vision loss and blindness. Corticosteroids are usually used as a second-line treatment. The aim of this study was to analyse the cost-effectiveness of dexamethasone implants compared to cheaper and more frequently applied triamcinolone injections. METHODS Markov-modelling, which incorporated both eyes, was used for economic evaluation. The model consisted of five health states based on visual acuity, illustrating the progression of DMO. A cycle length of five months was chosen for dexamethasone and four months for triamcinolone. Time horizons of two and five years were applied. Transition probabilities and health state utilities were sourced from previous studies. The perspective used in this analysis was the hospital perspective. The health care costs were acquired from Kuopio University Hospital in Finland. RESULTS In this cost-effectiveness analysis, the incremental cost-effectiveness ratio ICER with 3% discount rate was €56 591/QALY for a two-year follow-up and -€1 110 942/QALY for a five-year follow-up. In order to consider dexamethasone as cost-effective over a 2-year time horizon, the WTP needs to be around €55 000/QALY. Over the five-year follow-up, triamcinolone is clearly a dominant treatment. Sensitivity analyses support the cost-effectiveness of dexamethasone over a 2-year time horizon. CONCLUSIONS Since the sensitivity analyses support the results, dexamethasone would be a cost-effective treatment during the first two years with WTP threshold around €55 000/QALY, and triamcinolone would be a convenient treatment after that. This recommendation is in line with the guidelines of EURETINA.
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Affiliation(s)
| | | | - Pasi Vottonen
- Suomen Terveystalo Oy and University of Eastern FinlandKuopioFinland
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Neves P, Ornelas M, Matias I, Rodrigues J, Santos M, Dutra-Medeiros M, Martins D. Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes. Int J Ophthalmol 2021; 14:1571-1580. [PMID: 34667735 DOI: 10.18240/ijo.2021.10.15] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2020] [Accepted: 01/05/2021] [Indexed: 11/23/2022] Open
Abstract
AIM To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex®/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs). METHODS This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected. RESULTS Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported. CONCLUSION This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.
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Affiliation(s)
- Pedro Neves
- Department of Ophthalmology, Centro Hospitalar de Setúbal, Setúbal 2910-549, Portugal
| | - Mário Ornelas
- Department of Ophthalmology, Centro Hospitalar de Setúbal, Setúbal 2910-549, Portugal
| | - Inês Matias
- Department of Ophthalmology, Centro Hospitalar de Setúbal, Setúbal 2910-549, Portugal
| | - João Rodrigues
- Department of Ophthalmology, Hospital Beatriz Ângelo, Loures 2674-514, Portugal
| | - Margarida Santos
- Department of Ophthalmology, Hospital da Luz Setúbal, Setúbal 2900-722, Portugal
| | - Marco Dutra-Medeiros
- Department of Ophthalmology, Centro Hospitalar Lisboa Central, Faculdade de Ciências Médicas, NOVA University of Lisbon, Lisbon 1990-237, Portugal
| | - David Martins
- Department of Ophthalmology, Hospital da Luz Setúbal, Setúbal 2900-722, Portugal
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Augustin AJ, Becker MD, Hatz K, Kaymak H, Shirlaw A. Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland. Clin Ophthalmol 2021; 15:3957-3967. [PMID: 34616140 PMCID: PMC8489531 DOI: 10.2147/opth.s315548] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2021] [Accepted: 08/26/2021] [Indexed: 11/23/2022] Open
Abstract
PURPOSE The purpose was to assess the number and intervals of dexamethasone intravitreal implant (DEX) reinjections in a real-world setting for the treatment of diabetic macular edema (DME) and to determine the relationship with effectiveness and safety. PATIENTS AND METHODS Data were abstracted from medical records of DME patients in Germany and Switzerland for this retrospective, multicenter, drug utilization study. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) changes 7-12 weeks post-injection(s) measured effectiveness. Adverse events (AEs) of special interest were reported. RESULTS A total of 141 patients, 108 from Germany and 33 from Switzerland, were assessed. Mean (SD) reinjection interval was 5.7 (4.2) months. Mean baseline BCVA was 61.6 letters, and mean baseline CRT was 413.3 µm. The mean BCVA and CRT changes at 7-12 weeks after baseline, reinjection 1, 2, and 3 were +3.4, +3.7, +3.2, and -1.4 letters and -88.3, -81.6, -102.4, and -124.1 μm, respectively. The Spearman correlation between change in BCVA and CRT and DEX reinjection interval was r=0.03 (P=0.66) and r=0.07 (P=0.38), respectively. Only 18% of patients experienced at least 1 AE. CONCLUSION There was no statistically significant correlation between drug effectiveness and reinjection intervals in either country. Although these results are preliminary, they indicate that DEX improves BCVA and CRT in real-world clinical practice.
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Affiliation(s)
| | - Matthias D Becker
- Department of Ophthalmology, Zurich City Hospital, Zurich, Switzerland
- Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany
| | - Katja Hatz
- Vista Klinik Binningen, Switzerland and Faculty of Medicine, University of Basel, Basel, Switzerland
| | - Hakan Kaymak
- MVZ Macula and Retina Center Breyer, Kaymak, Klabe, Duesseldorf, Germany
| | - Andrew Shirlaw
- Allergan, an AbbVie company, Marlow, Buckinghamshire, UK
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Comparison of Intravitreal Dexamethasone Implant and Ranibizumab in Vitrectomized Eyes with Diabetic Macular Edema. J Ophthalmol 2021; 2021:8882539. [PMID: 34540287 PMCID: PMC8448602 DOI: 10.1155/2021/8882539] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2020] [Accepted: 08/26/2021] [Indexed: 11/17/2022] Open
Abstract
Purpose This retrospective study aimed to compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) for pseudophakic vitrectomized eyes with diabetic macular edema (DME) in a single institution. Methods Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME were enrolled, with one eye in each patient. They were divided into two groups: one group receiving IDI every 3 to 4 months and another group receiving IVR using 3 monthly plus treat-and-extend injections, all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser was not allowed. Primary outcome measures included change in central foveal thickness (CFT) in 1 mm by spectral-domain optical coherence tomography and best-corrected visual acuity (BCVA) at Month 6. Results Twenty-two eyes were included in the IDI group and 26 eyes in the IVR group. The baseline demographics, glycosylated hemoglobin level, intraocular pressure (IOP), BCVA, and CFT did not significantly differ (p > 0.05). Compared to baseline data, CFT decreased and BCVA improved significantly after either IDI or IVR at Month 6 (p < 0.05). Significantly better mean final BCVA (0.38 logMAR vs. 0.62 logMAR, p=0.04), more mean visual gain (−0.30 logMAR vs. −0.15 logMAR, p=0.02), lower mean final CFT (310.9 μm vs. 384.2 μm, p=0.04), and larger mean CFT decrease (−150.0 μm vs. −60.1 μm, p=0.03) were found in the IDI group compared to those in the IVR group. A smaller mean treatment number (2.6 vs. 5.6, p < 0.001) and higher rate of postinjection ocular hypertension requiring topical hypotensive agent therapy (27.3% vs. 0%, p=0.0002) were demonstrated in the IDI group than those in the IVR group. Conclusion We concluded that IDI and IVR can both effectively treat vitrectomized eyes with DME. Dexamethasone implants had significantly better visual/anatomical improvement, smaller treatment number, and higher rate of elevated IOP after injection than IVR in pseudophakic vitrectomized eyes with DME in a 6-month period.
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Karti O, Saatci AO. Place of intravitreal dexamethasone implant in the treatment armamentarium of diabetic macular edema. World J Diabetes 2021; 12:1220-1232. [PMID: 34512888 PMCID: PMC8394236 DOI: 10.4239/wjd.v12.i8.1220] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/27/2020] [Revised: 04/25/2021] [Accepted: 07/07/2021] [Indexed: 02/06/2023] Open
Abstract
Diabetic macular edema (DME) is a very important and well-known cause of visual loss in diabetics. Blood–retina barrier disruption and consequent intraretinal fluid accumulation may lead to retinal thickening at the posterior pole namely DME. Even though it is not clearly understood, current evidence suggests that chronic low-grade inflammation characterized with various cytokines has a major role in the occurrence of DME. Clinical trials are continuously shaping our treatment approaches for the eyes with DME. Today, vascular endothelial growth factor (VEGF) inhibitor and steroid administrations are the main alternatives in DME treatment. Dexamethasone (DEX) implant (Ozurdex®; Allergan, Inc., Irvine, CA, United States) was approved by the United States Food & Drug Administration in 2014 for DME treatment. The implant is made up of a biodegradable solid copolymer that is broken down by releasing its active ingredient into the vitreous cavity over time. Biphasic release feature of this sustained-release drug delivery system ensures its efficacy for up to 6 mo with an acceptable and manageable safety profile. DEX implant provides a favorable anatomical and functional outcome in DME as shown in several randomized-controlled studies but has a relatively higher ocular side-effect profile such as increased risk of cataract formation and raised intraocular pressure when compared to the gold standard anti-VEGF agents. Thus, DEX implant becomes the second-line treatment option demonstrating inadequate clinical response to anti-VEGF therapy. However, it can be preferred as the first-line treatment in vitrectomized and pseudophakic eyes. Even in some selected conditions DEX implant is favored over anti-VEGF agents where the use of VEGF-inhibitors is either inappropriate or contraindicated such as the patients with a recent history of a major cardiovascular or cerebrovascular event, pregnancy and noncompliant to frequent visits. This mini-review briefly overviews the efficacy, safety profile and complications of DEX implant and summarizes the outcome of DEX implant administration in major clinical studies on DME treatment.
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Affiliation(s)
- Omer Karti
- Department of Ophthalmology, İzmir Democracy University, İzmir 35330, Turkey
| | - Ali Osman Saatci
- Department of Ophthalmology, Dokuz Eylul University, İzmir 35330, Turkey
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Figueira J, Henriques J, Carneiro Â, Marques-Neves C, Flores R, Castro-Sousa JP, Meireles A, Gomes N, Nascimento J, Amaro M, Silva R. Guidelines for the Management of Center-Involving Diabetic Macular Edema: Treatment Options and Patient Monitorization. Clin Ophthalmol 2021; 15:3221-3230. [PMID: 34354341 PMCID: PMC8331083 DOI: 10.2147/opth.s318026] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2021] [Accepted: 06/15/2021] [Indexed: 02/05/2023] Open
Abstract
Diabetic macular edema (DME) is the main cause of visual impairment associated with diabetic retinopathy (DR) and macular laser, during approximately three decades, and was the single treatment option. More recently, intravitreous injections of anti-angiogenics and corticosteroids modified the treatment paradigm associated with significant vision improvements. Nevertheless, not all patients respond satisfactorily to anti-VEGF or corticosteroid injections, so an adequate treatment choice and a prompt switch in therapeutic class is recommended. Several algorithms and guidelines have been proposed for treating center involving DME to improve patients’ vision and quality of life. However, in Portugal, such guidelines are lacking. The present review aimed to provide guidelines for the treatment options and patient monitorization in the management of center-involving DME. We recommend anti-vascular endothelial growth factor (VEGF) as first-line therapy after a clinical evaluation accompanied by a rigorous metabolic control. Depending on the response obtained after 3–6 monthly intravitreal injections we suggest switching outside the class in case of a non-responder, maintaining the anti-VEGF-therapy in responders to anti-angiogenics. The treatment regimen for Dexamethasone intravitreal implant (DEXii) should be pro-re-nata with bi-monthly or quarterly monitoring visits (with a scheduled visit at 6–8 weeks after DEXii for intraocular pressure control). If a patient does not respond to DEXii, switch again to anti-VEGF therapy, combine therapies, or re-evaluate patients diagnose. There is a resilient need to understand the disease, its treatments, regimens available, and convenience for all involved to propose an adequate algorithm for the treatment of diabetic retinopathy (DR) and DME in an individualized regimen. Further understanding of the contributing factors to the development and progression of DR should bring new drug discoveries for more effective and better-tolerated treatments.
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Affiliation(s)
- João Figueira
- Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal; Faculty of Medicine, University of Coimbra (FMUC), Coimbra, Portugal.,AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal
| | - José Henriques
- Retina Department, Retinal Surgical Unit, Dr. Gama Pinto Ophthalmology Institute, Lisbon, Portugal
| | - Ângela Carneiro
- Department of Ophthalmology, Centro Hospitalar Universitário de São João, Porto, Portugal.,Department of Surgery and Physiology, Faculty of Medicine of University of Porto, Porto, Portugal
| | - Carlos Marques-Neves
- Department of Ophthalmology, Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon, Portugal.,Department of Ophthalmology, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.,ALM Oftalmolaser, Lisbon, Portugal
| | - Rita Flores
- Department of Ophthalmology, Centro Hospitalar de Lisboa Central EPE, Lisbon, Portugal.,CEDOC, Chronic Diseases Research Center, NOVA Medical School, Lisbon, Portugal
| | - João Paulo Castro-Sousa
- Department of Ophthalmology, Centro Hospitalar de Leiria, Leiria, Portugal.,CICS-UBI, Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal.,Faculty of Medical Sciences, Universidade da Beira Interior, Covilhã, Portugal
| | - Angelina Meireles
- Ophthalmology Department, Centro Hospitalar Universitário do Porto, Porto, Portugal.,Instituto de Ciências Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal
| | - Nuno Gomes
- Ophthalmology Department, Hospital de Braga, Braga, Portugal
| | - João Nascimento
- Instituto de Retina e Diabetes Oculares de Lisboa, Lisbon, Portugal
| | - Miguel Amaro
- Ophthalmology Department, Hospital Vila Franca de Xira, Vila Franca de Xira, Portugal
| | - Rufino Silva
- Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal; Faculty of Medicine, University of Coimbra (FMUC), Coimbra, Portugal.,AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.,Coimbra Medical Space, Coimbra, Portugal
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Udaondo P, Adan A, Arias-Barquet L, Ascaso FJ, Cabrera-López F, Castro-Navarro V, Donate-López J, García-Layana A, Lavid FJ, Rodríguez-Maqueda M, Ruiz-Moreno JM. Challenges in Diabetic Macular Edema Management: An Expert Consensus Report. Clin Ophthalmol 2021; 15:3183-3195. [PMID: 34349495 PMCID: PMC8327476 DOI: 10.2147/opth.s320948] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2021] [Accepted: 06/23/2021] [Indexed: 01/04/2023] Open
Abstract
Purpose This paper aimed to present daily-practice recommendations for the management of diabetic macular edema (DME) patients based on available scientific evidence and the clinical experience of the consensus panel. Methods A group of Spanish retina experts agreed to discuss different aspects related with the clinical management of DME patients. Results Panel was mainly focused on therapeutic objectives in DME management; definition terms; and role of biomarkers as prognostic and predictive factors to intravitreal treatment response. The panel recommends to start DME treatment as soon as possible in those eyes with a visual acuity less than 20/25 (always according to the retina unit capacity). Naïve patient was defined, in a strict manner, as a patient who, up to that moment, had never received any treatment. A refractory DME patient may be defined as the one who did not achieve a complete resolution of the disease, regardless of the treatment administered. Different optical coherence tomography biomarkers, such as disorganization of the retinal inner layers, hyperreflective dots, and cysts, have been identified as prognostic factors. Conclusion This document has sought to lay down a set of recommendations and to identify key issues that may be useful for the daily management of DME patients.
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Affiliation(s)
- Patricia Udaondo
- Department of Ophthalmology, Hospital Universitario y Politecnico la FE, Valencia, Spain
| | - Alfredo Adan
- Department of Ophthalmology, Hospital Clinic Barcelona, Barcelona, Spain
| | - Luis Arias-Barquet
- Department of Ophthalmology, University Complex Bellvitge, Barcelona, Spain
| | - Francisco J Ascaso
- Department of Ophthalmology, Hospital Universitario Lozano Blesa, Zaragoza, Spain
| | - Francisco Cabrera-López
- Department of Ophthalmology, Hospital Universitario Insular, Las Palmas de Gran Canaria, Spain
| | | | - Juan Donate-López
- Department of Ophthalmology, Hospital Clínico San Carlos, Madrid, Spain
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Whitescarver TD, Hobbs SD, Wade CI, Winegar JW, Colyer MH, Reddy AK, Drayna PM, Justin GA. A History of Anti-VEGF Inhibitors in the Ophthalmic Literature: A Bibliographic Review. JOURNAL OF VITREORETINAL DISEASES 2021; 5:304-312. [PMID: 37007592 PMCID: PMC9976233 DOI: 10.1177/2474126420971982] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Purpose: This work aimed to analyze the 100 most-cited articles on antivascular endothelial growth factor (anti-VEGF) inhibitors. Methods: A literature search for anti-VEGF inhibitors using the Web of Science was completed using the bibliographic databases for peer-reviewed literature published in Ophthalmology, the New England Journal of Medicine, Journal of the American Medical Association, and Lancet. Primary outcomes were the most frequently cited articles and journals with the most citations as well as the specific drug and disease process studied. Results: There were 42 696 cumulative citations among the top 100 articles. The articles were published between 2004 to 2016, with most articles published in 2006. Ophthalmology published the greatest number of articles among the top 100 at 48, whereas the New England Journal of Medicine has the most citations per publication at 1714. Ranibizumab was the medication researched in most articles at 56, followed by bevacizumab at 48, aflibercept at 10, and pegaptanib at 9. Forty-two articles investigated treatment of age-related macular degeneration, followed by 24 investigating diabetic macular edema, 10 for retinal vein occlusion, 8 for proliferative diabetic retinopathy, 2 for retinopathy of prematurity and polypoidal choroidal vasculopathy, and 1 for corneal neovascularization. Conclusions: As evidenced by the considerable number of citations accumulated over the past 20 years, anti-VEGF inhibitors have led to significant research in ophthalmology.
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Affiliation(s)
- Todd D. Whitescarver
- Department of Ophthalmology, Walter Reed National Military Medical Center, Bethesda, MD, USA
| | - Samuel D. Hobbs
- Department of Ophthalmology, Wilford Hall Eye Center, San Antonio, TX, USA
| | - Christian I. Wade
- School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
| | - Jordan W. Winegar
- Department of Ophthalmology, Walter Reed National Military Medical Center, Bethesda, MD, USA
| | - Marcus H. Colyer
- Department of Ophthalmology, Walter Reed National Military Medical Center, Bethesda, MD, USA
- Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
| | - Ashvini K. Reddy
- Department of Ophthalmology, University of Texas Health Science Center, San Antonio, TX, USA
| | - Paul M. Drayna
- Department of Ophthalmology, Wilford Hall Eye Center, San Antonio, TX, USA
| | - Grant A. Justin
- Department of Ophthalmology, Walter Reed National Military Medical Center, Bethesda, MD, USA
- Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
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Diabetic retinopathy and diabetic macular oedema pathways and management: UK Consensus Working Group. Eye (Lond) 2021; 34:1-51. [PMID: 32504038 DOI: 10.1038/s41433-020-0961-6] [Citation(s) in RCA: 100] [Impact Index Per Article: 25.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
The management of diabetic retinopathy (DR) has evolved considerably over the past decade, with the availability of new technologies (diagnostic and therapeutic). As such, the existing Royal College of Ophthalmologists DR Guidelines (2013) are outdated, and to the best of our knowledge are not under revision at present. Furthermore, there are no other UK guidelines covering all available treatments, and there seems to be significant variation around the UK in the management of diabetic macular oedema (DMO). This manuscript provides a summary of reviews the pathogenesis of DR and DMO, including role of vascular endothelial growth factor (VEGF) and non-VEGF cytokines, clinical grading/classification of DMO vis a vis current terminology (of centre-involving [CI-DMO], or non-centre involving [nCI-DMO], systemic risks and their management). The excellent UK DR Screening (DRS) service has continued to evolve and remains world-leading. However, challenges remain, as there are significant variations in equipment used, and reproducible standards of DMO screening nationally. The interphase between DRS and the hospital eye service can only be strengthened with further improvements. The role of modern technology including optical coherence tomography (OCT) and wide-field imaging, and working practices including virtual clinics and their potential in increasing clinic capacity and improving patient experiences and outcomes are discussed. Similarly, potential roles of home monitoring in diabetic eyes in the future are explored. The role of pharmacological (intravitreal injections [IVT] of anti-VEGFs and steroids) and laser therapies are summarised. Generally, IVT anti-VEGF are offered as first line pharmacologic therapy. As requirements of diabetic patients in particular patient groups may vary, including pregnant women, children, and persons with learning difficulties, it is important that DR management is personalised in such particular patient groups. First choice therapy needs to be individualised in these cases and may be intravitreal steroids rather than the standard choice of anti-VEGF agents. Some of these, but not all, are discussed in this document.
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INTRAVITREAL DEXAMETHASONE IMPLANT MIGRATION INTO THE ANTERIOR CHAMBER: A Multicenter Study From the Pan-American Collaborative Retina Study Group. Retina 2021; 40:825-832. [PMID: 30789460 DOI: 10.1097/iae.0000000000002475] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
PURPOSE To establish the prevalence and risk factors for intravitreal dexamethasone implant migration into the anterior chamber in eyes with macular edema. METHODS This was a multicenter, retrospective, observational chart review of data that included patients with macular edema who had been treated with at least one intravitreal dexamethasone injection. Patients with incomplete chart information during the follow-up period were excluded. RESULTS The prevalence of implant migration in 468 patients, considering the number of injections, was 1.6%, with significant associations between implant migration and cataract surgery (P = 0.043) and intraocular lens status (P = 0.005) and a trend toward statistical significance (P = 0.057) with vitrectomy. A higher rate of implant migration into the anterior chamber was observed in vitrectomized eyes (4.8%) when compared with patients who did not undergo a vitrectomy (1.6%). The implants that migrated were removed with forceps with/without viscoelastic expression or with 20-gauge cannulas connected to the vitreous cutter machine. CONCLUSION The risk of implant migration into the anterior chamber was 1.6%. Risk factors were a history of cataract surgery or vitrectomy and aphakia. When anterior migration occurs, rapid removal is advised, especially if corneal edema is present.
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BILATERAL INTRAVITREAL 0.19-MG FLUOCINOLONE ACETONIDE IMPLANT FOR PERSISTENT NONDIABETIC CYSTOID MACULAR EDEMA AFTER VITRECTOMY. Retin Cases Brief Rep 2021; 15:261-265. [PMID: 30015770 DOI: 10.1097/icb.0000000000000779] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
BACKGROUND/PURPOSE Iluvien (Alimera Science, Alpharetta, GA) is an injectable, nonbiodegradable, sustained-release 0.19-mg fluocinolone acetonide intravitreal implant. Although currently approved by the Food and Drug Administration only for diabetic macular edema previously treated with a course of corticosteroids without a clinically significant intraocular pressure response, the 0.19-mg fluocinolone acetonide implant could theoretically be used to treat other noninfectious inflammatory conditions including persistent cystoid macular edema because of nondiabetic etiologies. METHODS Interventional case report. A 79-year-old man had persistent cystoid macular edema after pars plana vitrectomy in both eyes that was refractory to topical treatments and intravitreal anti-vascular endothelial growth factor. His cystoid macular edema was responsive to preservative-free intravitreal triamcinolone acetonide after which he developed noninfectious endophthalmitis or pseudoendophthalmitis in both eyes precluding further intravitreal triamcinolone acetonide injections. He was subsequently treated with bilateral intravitreal 0.19-mg fluocinolone acetonide implants. RESULTS At the most recent post-treatment follow-up (11 months for the right eye and 13 months for the left eye), the patient demonstrated an improvement in visual acuity, 20/126 to 20/50 in the right eye and 20/80 to 20/40 in the left eye, and in central subfield thickness, 592 μm to 288 μm in the right eye and 565 μm to 287 μm in the left eye, without intraocular pressure elevation. CONCLUSION The intravitreal 0.19-mg fluocinolone acetonide implant is an effective and potentially safe off-label therapeutic option for persistent nondiabetic cystoid macular edema after vitrectomy.
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Furino C, Boscia F, Niro A, D'Addario M, Grassi MO, Saglimbene V, Reibaldi M, Alessio G. DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard Phacoemulsification. Retina 2021; 41:1102-1109. [PMID: 32897932 PMCID: PMC8078110 DOI: 10.1097/iae.0000000000002974] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
PURPOSE To compare functional and anatomical results of combined phacoemulsification and dexamethasone intravitreal implant (Ozurdex; DEX-I) with standard phacoemulsification in diabetic patients with cataract. METHODS Retrospective, comparative, cohort study. Patients with nonproliferative diabetic retinopathy, macular edema, and cataract, treated routinely at the Eye Clinic, Azienda Ospedaliero Universitaria Policlinico, Bari, Italy with phacoemulsification associated with DEX-I (n = 23; Phaco-Dex) or standard phacoemulsification (n = 23; Phaco-alone). Best-correct visual acuity, central subfield thickness, and intraocular pressure were assessed at baseline and monthly for 3 months after surgery, and t-test was used to assess change from baseline. A multilevel regression model with an unstructured correlation-type matrix to account for repeated data measures was used for statistical analysis in and between groups. RESULTS With Phaco-Dex, best-correct visual acuity increased significantly from the first month (P = 0.0005 vs. baseline) and remained stable at the following visits; central subfield thickness decreased significantly from Month 2 (P = 0.049 and P = 0.04 vs. baseline, respectively); at each timepoint, central subfield thickness was significantly lower in the Phaco-Dex group versus Phaco-alone. Intraocular pressure increased significantly during follow-up (P = 0.001 at Month 3 vs. baseline) but remained within the normal range. In the Phaco-alone group, best-correct visual acuity, and intraocular pressure did not show any significant changes after surgery, whereas central subfield thickness increased from Month 2 (P = 0.05 vs. baseline). CONCLUSION In diabetic patients with macular edema and visually significant cataract, combined treatment with phacoemulsification and DEX-I seemed to be effective, safe, and superior to standard phacoemulsification considering both functional and tomographic parameters.
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Affiliation(s)
- Claudio Furino
- Department of Medical Science, Neuroscience and Sense Organs, Eye Clinic, Azienda Ospedaliero-Universitaria Policlinico Consorziale Bari, Italy;
| | - Francesco Boscia
- Department of Medical Science, Neuroscience and Sense Organs, Eye Clinic, University of Bari, Bari, Italy;
| | | | - Maria D'Addario
- Department of Medical Science, Neuroscience and Sense Organs, Eye Clinic, Azienda Ospedaliero-Universitaria Policlinico Consorziale Bari, Italy;
| | - Maria O. Grassi
- Department of Medical Science, Neuroscience and Sense Organs, Eye Clinic, Azienda Ospedaliero-Universitaria Policlinico Consorziale Bari, Italy;
| | - Valeria Saglimbene
- Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia; and
| | | | - Giovanni Alessio
- Department of Medical Science, Neuroscience and Sense Organs, Eye Clinic, Azienda Ospedaliero-Universitaria Policlinico Consorziale Bari, Italy;
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Bravetti GE, Vaudaux J, Pournaras JA, Ambresin A. Persistent Remnants of Dexamethasone Intravitreal Implant Over 24 Months in a Patient Suffering from Anterior and Intermediate Uveitis Associated with Macular Edema. Klin Monbl Augenheilkd 2021; 238:454-457. [PMID: 33930917 DOI: 10.1055/a-1384-1056] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Affiliation(s)
- Giorgio Enrico Bravetti
- Retina Department, Ophthalmology Center, RétinElysée, Lausanne, Switzerland, Lausanne, Switzerland
| | - Jean Vaudaux
- Retina Department, Ophthalmology Center, RétinElysée, Lausanne, Switzerland, Lausanne, Switzerland.,Ophthalmology, Private practice, Morges, Switzerland
| | - Jean-Antoine Pournaras
- Retina Department, Ophthalmology Center, RétinElysée, Lausanne, Switzerland, Lausanne, Switzerland
| | - Aude Ambresin
- Retina Department, Ophthalmology Center, RétinElysée, Lausanne, Switzerland, Lausanne, Switzerland.,Opthalmology Departement, Swiss Visio, Clinique de Montchoisi, Lausanne, Switzerland, Lausanne, Switzerland
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Parisi G, Fallico M, Avitabile T, Longo A, Ortisi E, Russo A, Petrillo F, Maugeri A, Barchitta M, Bonfiglio V, Furino C, Cennamo G, Caselgrandi P, Marolo P, Ventre L, Reibaldi M. Intravitreal Dexamethasone Implant for Postoperative Macular Oedema Secondary to Vitrectomy for Epiretinal Membrane and Retinal Detachment: A Systematic Review and Meta-Analysis. J Ophthalmol 2021; 2021:6627677. [PMID: 33953965 PMCID: PMC8064798 DOI: 10.1155/2021/6627677] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2020] [Revised: 03/06/2021] [Accepted: 04/05/2021] [Indexed: 01/01/2023] Open
Abstract
PURPOSE To evaluate the efficacy of intravitreal dexamethasone implant (DEX) for the treatment of macular oedema secondary to vitrectomy for epiretinal membrane (ERM) and retinal detachment (RD) by conducting a systematic review with meta-analysis of published studies. METHODS Studies reporting clinical outcomes of DEX use for the treatment of macular oedema secondary to ERM and RD vitrectomy were searched on PubMed and Embase databases. The primary outcome was best-corrected visual acuity (BCVA) change between baseline and post-DEX treatment, reported as mean difference (MD) with 95% confidence interval (CI). Mean central macular thickness (CMT) change was assessed as a secondary outcome. Postimplant adverse events, including intraocular pressure rise and cataract development, were reported as well. RESULTS Five uncontrolled studies, 1 nonrandomized controlled study, and 1 randomized controlled study were included, with a total of 5 cohorts and 3 cohorts in the ERM group and RD group, respectively. Considering the last available follow-up, a significant improvement in postimplant BCVA was found in the overall population, irrespective of the indication for vitrectomy (MD = -0.28, 95% CI = -0.37, -0.20; p < 0.001), but with significant heterogeneity. In either group, mean BCVA significantly improved following the implant (in the ERM group, MD = -0.31, 95% CI = -0.40, -0.22; in the RD group, MD = -0.22, 95% CI = -0.41, -0.03), with no difference between the two groups (p=0.41). However, there was significant heterogeneity in both groups. Considering the last available follow-up, a significant CMT reduction was found in the overall population, irrespective of the indication for vitrectomy (MD = -129.75, 95% CI = -157.49, -102.01; p < 0.001). In the ERM group, a significant CMT reduction was shown following DEX (MD = -133.41, 95% CI = -155.37, -111.45; p < 0.001), with no heterogeneity. In the RD group, mean CMT reduction was borderline significant (MD = -128.37, 95% CI = -253.57, -3.18; p=0.040), with significant heterogeneity. No difference in CMT improvement was found between the two groups (p=0.94). CONCLUSION This meta-analysis showed that DEX yielded a significant improvement in visual and anatomical outcomes, even if limited by significant heterogeneity. Dexamethasone implant represents an effective treatment for postoperative macular oedema secondary to ERM and RD vitrectomy.
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Affiliation(s)
- Guglielmo Parisi
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin 10122, Italy
| | - Matteo Fallico
- Department of Ophthalmology, University of Catania, Catania 95100, Italy
| | - Teresio Avitabile
- Department of Ophthalmology, University of Catania, Catania 95100, Italy
| | - Antonio Longo
- Department of Ophthalmology, University of Catania, Catania 95100, Italy
| | - Elina Ortisi
- Department of Ophthalmology, University of Catania, Catania 95100, Italy
| | - Andrea Russo
- Department of Ophthalmology, University of Catania, Catania 95100, Italy
| | - Francesco Petrillo
- Department of Ophthalmology, University of Catania, Catania 95100, Italy
| | - Andrea Maugeri
- Department of Medical and Surgical Sciences and Advanced Technologies “GF Ingrassia”, University of Catania, Catania, Italy
| | - Martina Barchitta
- Department of Medical and Surgical Sciences and Advanced Technologies “GF Ingrassia”, University of Catania, Catania, Italy
| | - Vincenza Bonfiglio
- Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo, Palermo 90127, Italy
| | - Claudio Furino
- Department of Ophthalmology, University of Bari, Bari, Italy
| | - Gilda Cennamo
- Department of Public Health, University of Naples Federico II, Naples, Italy
| | - Paolo Caselgrandi
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin 10122, Italy
| | - Paola Marolo
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin 10122, Italy
| | - Luca Ventre
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin 10122, Italy
| | - Michele Reibaldi
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin 10122, Italy
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Fallico M, Maugeri A, Romano GL, Bucolo C, Longo A, Bonfiglio V, Russo A, Avitabile T, Barchitta M, Agodi A, Pignatelli F, Marolo P, Ventre L, Parisi G, Reibaldi M. Epiretinal Membrane Vitrectomy With and Without Intraoperative Intravitreal Dexamethasone Implant: A Systematic Review With Meta-Analysis. Front Pharmacol 2021; 12:635101. [PMID: 33935724 PMCID: PMC8082723 DOI: 10.3389/fphar.2021.635101] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2020] [Accepted: 03/16/2021] [Indexed: 01/01/2023] Open
Abstract
Purpose: To evaluate the efficacy of vitrectomy combined with intravitreal dexamethasone implant vs. vitrectomy without the implant in patients with epiretinal membrane (ERM) by conducting a systematic review and meta-analysis. Methods: Studies that compared ERM vitrectomy with and without intraoperative dexamethasone implant with a follow-up ≥3 months were included. The primary outcome was mean best corrected visual acuity (BCVA) change between eyes undergoing ERM vitrectomy combined with dexamethasone implant (DEX group) and eyes undergoing ERM vitrectomy alone (control group) at 3 months. Secondary outcomes included mean BCVA change at 6 months and mean optical coherence tomography central macular thickness (CMT) change at both 3-months and 6-months follow-up. Mean differences (MDs) with their 95% confidence interval (95%CI) were calculated. Meta-analyses were based either on random effect model or fixed effect model according to heterogeneity. Results: Four studies were included. At 3 months, ERM vitrectomy combined with dexamethasone implant yielded a greater visual gain compared to vitrectomy alone (MD = 9.7; 95%CI = 2.6–16.8; p = 0.01). However, significant heterogeneity was found. A sensitivity analysis excluding the only retrospective non-randomized study confirmed a greater visual gain in the DEX group (MD = 7.1; 95%CI = 2.7–11.6; p < 0.01), with no heterogeneity. At 6 months, a non-significant but borderline difference in visual gain was shown between in the two groups (MD = 5.1; 95%CI = −0.3–10.5; p = 0.06), with no heterogeneity. Three-month analysis of CMT revealed a greater reduction in the DEX group (MD = −80.2; 95%CI =−149.1–11.2; p = 0.02), but with significant heterogeneity. A sensitivity analysis excluding the only retrospective non-randomized study allowed to reduce heterogeneity, but no difference in 3-months CMT change was found between the two groups (MD = −50.0; 95%CI = −106.2–6.2; p = 0.08). At 6 months, no difference in CMT change was shown between the two groups (MD = −48.5; 95%CI = −120.5–23.5; p = 0.19), with significant heterogeneity. Conclusions: Intraoperative dexamethasone implant in eyes undergoing vitrectomy for ERM provided a better visual outcome at 3 months compared to ERM vitrectomy without the implant, with limited evidence of better anatomic outcome as well. Further studies are needed to ascertain whether dexamethasone implant would ensure a significant long-term visual benefit as a result of a faster reduction of macular thickening.
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Affiliation(s)
- Matteo Fallico
- Department of Ophthalmology, University of Catania, Catania, Italy
| | - Andrea Maugeri
- Department of Medical and Surgical Sciences and Advanced Technologies "GF Ingrassia", University of Catania, Catania, Italy
| | - Giovanni L Romano
- Department of Biomedical and Biotechnological Sciences, School of Medicine, University of Catania, Catania, Italy.,Center for Research in Ocular Pharmacology-CERFO, University of Catania, Catania, Italy
| | - Claudio Bucolo
- Department of Biomedical and Biotechnological Sciences, School of Medicine, University of Catania, Catania, Italy.,Center for Research in Ocular Pharmacology-CERFO, University of Catania, Catania, Italy
| | - Antonio Longo
- Department of Ophthalmology, University of Catania, Catania, Italy
| | - Vincenza Bonfiglio
- Department of Experimental Biomedicine and Clinical Neuroscience, Ophthalmology Section, University of Palermo, Palermo, Italy
| | - Andrea Russo
- Department of Ophthalmology, University of Catania, Catania, Italy
| | | | - Martina Barchitta
- Department of Medical and Surgical Sciences and Advanced Technologies "GF Ingrassia", University of Catania, Catania, Italy
| | - Antonella Agodi
- Department of Medical and Surgical Sciences and Advanced Technologies "GF Ingrassia", University of Catania, Catania, Italy
| | | | - Paola Marolo
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy
| | - Luca Ventre
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy
| | - Guglielmo Parisi
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy
| | - Michele Reibaldi
- Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy
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