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Sanjana Chouhan S, Neelamegam V, Raghu K, Surya RJ, Janarthanam JB, Rao C, Mohapatra A, Raman R. Diagnostic Utility of Swept-Source OCT-Based Biometry and Fundus Photographs Compared to Spectral Domain OCT in Center-Involving Diabetic Macular Edema. Ophthalmic Epidemiol 2025; 32:95-102. [PMID: 38709173 DOI: 10.1080/09286586.2024.2338824] [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: 01/22/2024] [Revised: 03/23/2024] [Accepted: 03/29/2024] [Indexed: 05/07/2024]
Abstract
PURPOSE This study was aimed to evaluate the agreement between the swept-source optical coherence tomography (SS-OCT)-based biometry, fundus photographs, and their combination, in comparison to the gold standard spectral-domain optical coherence tomography (SD-OCT) for the detection of center-involving diabetic macular edema (CI-DME). METHODS We conducted a retrospective cross-sectional study involving 55 subjects (78 eyes) diagnosed with diabetic macular edema (DME) detected clinically and on SD-OCT (Carl Zeiss Meditec AG). Post-mydriatic 45-degree color fundus photograph (Crystal-Vue NFC-700), 1 mm macular scan obtained from SS-OCT-based biometry (IOL-Master 700), and macula cube scan obtained from SD-OCT was used to detect and grade DME into CI-DME and NCI-DME. RESULTS Our findings revealed that SS-OCT-based biometry was noted to have a high sensitivity of 1 (0.94-1.00) and a specificity of 0.63 (0.31-0.89) in detecting CI-DME compared to the gold standard (SD-OCT). When combined with data from fundus photographs, specificity decreased to 0.32 (0.15-0.53). Fundus photographs alone exhibited a low sensitivity of 0.52 (0.38-0.64) and a specificity of 0.45 (0.16-0.76) in CI-DME detection. CONCLUSION In conclusion, SS-OCT-based biometry can be used as an effective tool for the detection of CI-DME in diabetic patients undergoing cataract surgery and can serve as a screening tool in centers without SD-OCT facilities.
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Affiliation(s)
- S Sanjana Chouhan
- Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, India
| | - Vidya Neelamegam
- Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, India
| | - Keerthana Raghu
- Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, India
| | - R Janani Surya
- Biostatistics, National Institute of Epidemiology, Chennai, India
| | | | - Chetan Rao
- Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, India
| | - Ayushi Mohapatra
- Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, India
| | - Rajiv Raman
- Shri Bhagwan Mahavir Vitreoretinal Services, Sankara Nethralaya, Chennai, India
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Sivarasu M, Madheswaran G, Balasubramaniam SS, Balasubramaniam C. Optical coherence tomography findings in patients with diabetic macular edema: A retrospective analysis. Oman J Ophthalmol 2025; 18:22-27. [PMID: 40124456 PMCID: PMC11925365 DOI: 10.4103/ojo.ojo_23_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2024] [Accepted: 12/02/2024] [Indexed: 03/25/2025] Open
Abstract
BACKGROUND Diabetic macular edema (DME) is a leading cause of vision loss in diabetic people. DME can be treated with various medications, including intravitreal injections, laser therapy, and surgery. Early detection and treatment of DME is essential to prevent vision loss. The study aimed to describe patients' demographic and clinical characteristics with DME, optical coherence tomography (OCT) findings, and visual acuity outcomes. METHODOLOGY A retrospective study reviewed case records of patients with DME between 2017 and 2020. Demographic data, clinical characteristics, and examination results were extracted and analyzed using Microsoft Excel (2013). All patients clinically diagnosed with DME underwent assessment by OCT examination. DME was classified based on OCT findings. Statistical significance was observed at P < 0.05. RESULTS This retrospective study included 213 eyes of 134 patients, of which 77.6% were male and 22.4% were female. Nonproliferative diabetic retinopathy (NPDR) was present in 51.64% of eyes, and PDR was present in 48.36%. Focal, diffuse, and cystoid macular edema was observed in 68, 31, and 65 eyes, respectively. Tractional macular edema was seen in 16 eyes with posterior hyaloid traction, 13 with epiretinal membrane (ERM), and one with both conditions. DME associated with subretinal fluid (SRF) detachment was seen in 8.92% of eyes. The mean (standard deviation) central retinal thickness was 284.5 (28.9), 434.0 (97.5), 426.5 (27.5), 510.5 (14.1), and 465.5 (280.7) μm in focal, diffuse, cystoid, ERM, and SRF, respectively. Increased central retinal thickness was associated with decreased visual acuity (P < 0.05). CONCLUSION The findings of this study suggest that DME is a common and visually significant complication of diabetes. The OCT findings can be used to classify DME into different subtypes, which may help to guide treatment decisions. Focal edema was the most common type of DME with the least central retinal thickness. In NPDR, focal macular edema was the most common; in PDR, cystoid edema was the most common. Cystoid edema was the most common type in the subgroup of patients with recurrent DME following anti-vascular endothelial growth factor injection.
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Affiliation(s)
- Manjunathan Sivarasu
- Department of Ophthalmology, Acchutha Eye Care and Postgraduate Institute of Ophthalmology, Erode, Tamil Nadu, India
- Department of Optometry, Acchutha Institute of Optometry, Erode, Tamil Nadu, India
| | - Gopinath Madheswaran
- Department of Ophthalmology, Acchutha Eye Care and Postgraduate Institute of Ophthalmology, Erode, Tamil Nadu, India
- Department of Optometry, Acchutha Institute of Optometry, Erode, Tamil Nadu, India
| | - Saranya Sachi Balasubramaniam
- Department of Ophthalmology, Acchutha Eye Care and Postgraduate Institute of Ophthalmology, Erode, Tamil Nadu, India
- Department of Optometry, Acchutha Institute of Optometry, Erode, Tamil Nadu, India
| | - Chinnasamy Balasubramaniam
- Department of Ophthalmology, Acchutha Eye Care and Postgraduate Institute of Ophthalmology, Erode, Tamil Nadu, India
- Department of Optometry, Acchutha Institute of Optometry, Erode, Tamil Nadu, India
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Venkatesh R, Jayadev C, Prabhu V, Gandhi P, Kathare R, Yadav NK, Choudhary A, Chhablani J. Pharmacological adjuvants for diabetic vitrectomy surgery. World J Methodol 2024; 14:92246. [PMID: 39712567 PMCID: PMC11287545 DOI: 10.5662/wjm.v14.i4.92246] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2024] [Revised: 06/26/2024] [Accepted: 07/05/2024] [Indexed: 07/26/2024] Open
Abstract
Diabetic vitrectomy is a highly intricate surgical procedure performed during the advanced stages of diabetic retinopathy (DR). It is used to treat conditions such as tractional or combined retinal detachment, vitreous hemorrhage, and subhyaloid hemorrhage, which are all severe manifestations of proliferative DR. The results of the surgery are uncertain and variable. Vitreoretinal surgery has made significant progress since the early stages of vitrectomy. In the past ten years, advancements in intravitreal pharmacotherapy have emerged, offering new possibilities to improve the surgical results for our patients. Within the realm of medical terminology, an "adjunct" refers to a pharmaceutical or substance employed to aid or expedite the primary therapeutic intervention for a particular ailment. Their introduction has broadened the range of therapeutic choices that are accessible prior to, during, and following surgical procedures. This review article will specifically analyze the pharmacological adjuncts used in diabetic vitrectomy surgery, with a focus on their role in facilitating or aiding specific steps of the procedure. The implementation of this system of categorization offers benefits to the surgeon by allowing them to foresee potential difficulties that may occur during the surgical procedure and to choose the appropriate pharmacological agent to effectively tackle these challenges, thus enhancing surgical success rates.
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Affiliation(s)
- Ramesh Venkatesh
- Department of Ophthalmology, Narayana Nethralaya, Bangalore 560010, India
| | - Chaitra Jayadev
- Department of Retina, Narayana Nethralaya Eye Institute, Bangalore 560010, India
| | - Vishma Prabhu
- Department of Retina, Narayana Nethralaya Eye Institute, Bangalore 560010, India
| | - Priyanka Gandhi
- Department of Retina, Narayana Nethralaya Eye Institute, Bangalore 560010, India
| | - Rupal Kathare
- Department of Retina, Narayana Nethralaya Eye Institute, Bangalore 560010, India
| | - Naresh K Yadav
- Department of Vitreo Retina, Narayana Nethralaya, Retina Serv, Super Specialty Eye Hospital and Post Graduate Institute of Ophthalmology, Bangalore 560010, India
| | - Ayushi Choudhary
- Department of Retina, Narayana Nethralaya Eye Institute, Bangalore 560010, India
| | - Jay Chhablani
- Department of Retina, University of Pittsburg School of Medicine, Pittsburg, PA 15213, United States
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Choudhary A, Gopalakrishnan N, Joshi A, Balakrishnan D, Chhablani J, Yadav NK, Reddy NG, Rani PK, Gandhi P, Shetty R, Roy R, Bavaskar S, Prabhu V, Venkatesh R. Recommendations for diabetic macular edema management by retina specialists and large language model-based artificial intelligence platforms. Int J Retina Vitreous 2024; 10:22. [PMID: 38419083 PMCID: PMC10900631 DOI: 10.1186/s40942-024-00544-6] [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: 01/13/2024] [Accepted: 02/15/2024] [Indexed: 03/02/2024] Open
Abstract
PURPOSE To study the role of artificial intelligence (AI) in developing diabetic macular edema (DME) management recommendations by creating and comparing responses to clinicians in hypothetical AI-generated case scenarios. The study also examined whether its joint recommendations followed national DME management guidelines. METHODS The AI hypothetically generated 50 ocular case scenarios from 25 patients using keywords like age, gender, type, duration and control of diabetes, visual acuity, lens status, retinopathy stage, coexisting ocular and systemic co-morbidities, and DME-related retinal imaging findings. For DME and ocular co-morbidity management, we calculated inter-rater agreements (kappa analysis) separately for clinician responses, AI-platforms, and the "majority clinician response" (the maximum number of identical clinician responses) and "majority AI-platform" (the maximum number of identical AI responses). Treatment recommendations for various situations were compared to the Indian national guidelines. RESULTS For DME management, clinicians (ĸ=0.6), AI platforms (ĸ=0.58), and the 'majority clinician response' and 'majority AI response' (ĸ=0.69) had moderate to substantial inter-rate agreement. The study showed fair to substantial agreement for ocular co-morbidity management between clinicians (ĸ=0.8), AI platforms (ĸ=0.36), and the 'majority clinician response' and 'majority AI response' (ĸ=0.49). Many of the current study's recommendations and national clinical guidelines agreed and disagreed. When treating center-involving DME with very good visual acuity, lattice degeneration, renal disease, anaemia, and a recent history of cardiovascular disease, there were clear disagreements. CONCLUSION For the first time, this study recommends DME management using large language model-based generative AI. The study's findings could guide in revising the global DME management guidelines.
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Affiliation(s)
- Ayushi Choudhary
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Nikhil Gopalakrishnan
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Aishwarya Joshi
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Divya Balakrishnan
- Dept of Retina and Vitreous, Little Flower Hospital and Research Centre, 683572, Angamaly, Kerala, India
| | - Jay Chhablani
- Medical Retina and Vitreoretinal Surgery, University of Pittsburgh School of Medicine, 203 Lothrop Street, Suite 800, 15213, Pittsburg, PA, USA
| | - Naresh Kumar Yadav
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Nikitha Gurram Reddy
- Anant Bajaj Retina Institute, L V Prasad Eye Institute, Kallam Anji Reddy Campus, 500034, Hyderabad, Telangana, India
| | - Padmaja Kumari Rani
- Anant Bajaj Retina Institute, L V Prasad Eye Institute, Kallam Anji Reddy Campus, 500034, Hyderabad, Telangana, India
| | - Priyanka Gandhi
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Rohit Shetty
- Dept. of Cornea and Refractive Services, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Rupak Roy
- Dept. of Vitreo-Retina, Aditya Birla Sankara Nethralaya, 700099, Kolkata, India
| | - Snehal Bavaskar
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Vishma Prabhu
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Ramesh Venkatesh
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India.
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Salvetat ML, Pellegrini F, Spadea L, Salati C, Musa M, Gagliano C, Zeppieri M. The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When. J Clin Med 2024; 13:1327. [PMID: 38592149 PMCID: PMC10932454 DOI: 10.3390/jcm13051327] [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: 12/11/2023] [Revised: 02/13/2024] [Accepted: 02/21/2024] [Indexed: 04/10/2024] Open
Abstract
Diabetic macular edema (DME) is a common complication of diabetes mellitus and a leading cause of visual impairment worldwide. It is defined as the diabetes-related accumulation of fluid, proteins, and lipids, with retinal thickening, within the macular area. DME affects a significant proportion of individuals with diabetes, with the prevalence increasing with disease duration and severity. It is estimated that approximately 25-30% of diabetic patients will develop DME during their lifetime. Poor glycemic control, hypertension, hyperlipidemia, diabetes duration, and genetic predisposition are recognized as risk factors for the development and progression of DME. Although the exact pathophysiology is still not completely understood, it has been demonstrated that chronic hyperglycemia triggers a cascade of biochemical processes, including increased oxidative stress, inflammation, activation of vascular endothelial growth factor (VEGF), cellular dysfunction, and apoptosis, with breakdown of the blood-retinal barriers and fluid accumulation within the macular area. Early diagnosis and appropriate management of DME are crucial for improving visual outcomes. Although the control of systemic risk factors still remains the most important strategy in DME treatment, intravitreal pharmacotherapy with anti-VEGF molecules or steroids is currently considered the first-line approach in DME patients, whereas macular laser photocoagulation and pars plana vitrectomy may be useful in selected cases. Available intravitreal steroids, including triamcinolone acetonide injections and dexamethasone and fluocinolone acetonide implants, exert their therapeutic effect by reducing inflammation, inhibiting VEGF expression, stabilizing the blood-retinal barrier and thus reducing vascular permeability. They have been demonstrated to be effective in reducing macular edema and improving visual outcomes in DME patients but are associated with a high risk of intraocular pressure elevation and cataract development, so their use requires an accurate patient selection. This manuscript aims to provide a comprehensive overview of the pathology, epidemiology, risk factors, physiopathology, clinical features, treatment mechanisms of actions, treatment options, prognosis, and ongoing clinical studies related to the treatment of DME, with particular consideration of intravitreal steroids therapy.
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Affiliation(s)
- Maria Letizia Salvetat
- Department of Ophthalmology, Azienda Sanitaria Friuli Occidentale, 33170 Pordenone, Italy; (M.L.S.)
| | - Francesco Pellegrini
- Department of Ophthalmology, Azienda Sanitaria Friuli Occidentale, 33170 Pordenone, Italy; (M.L.S.)
| | - Leopoldo Spadea
- Eye Clinic, Policlinico Umberto I, “Sapienza” University of Rome, 00142 Rome, Italy
| | - Carlo Salati
- Department of Ophthalmology, University Hospital of Udine, 33100 Udine, Italy
| | - Mutali Musa
- Department of Optometry, University of Benin, Benin City 300238, Edo State, Nigeria
| | - Caterina Gagliano
- Faculty of Medicine and Surgery, University of Enna “Kore”, Piazza dell’Università, 94100 Enna, Italy
- Eye Clinic, Catania University, San Marco Hospital, Viale Carlo Azeglio Ciampi, 95121 Catania, Italy
| | - Marco Zeppieri
- Department of Ophthalmology, University Hospital of Udine, 33100 Udine, Italy
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Mishra C, Mohanty N. The role of real-world studies in the management of non-center-involving diabetic macular edema. Indian J Ophthalmol 2024; 72:289-290. [PMID: 38273686 PMCID: PMC10941944 DOI: 10.4103/ijo.ijo_1411_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/27/2024] Open
Affiliation(s)
- Chitaranjan Mishra
- Department of Vitreo-Retina Services, Trilochan Netralaya, Budharaja, Sambalpur, Odisha, India
| | - Nabatika Mohanty
- Department of Vitreo-Retina Services, Trilochan Netralaya, Budharaja, Sambalpur, Odisha, India
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Kour V, Swain J, Singh J, Singh H, Kour H. A Review on Diabetic Retinopathy. Curr Diabetes Rev 2024; 20:e201023222418. [PMID: 37867267 DOI: 10.2174/0115733998253672231011161400] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/24/2023] [Revised: 07/08/2023] [Accepted: 08/23/2023] [Indexed: 10/24/2023]
Abstract
Diabetic retinopathy is a well-recognised microvascular complication of diabetes and is among the leading cause of blindness all over the world. Over the last decade, there have been advances in the diagnosis of diabetic retinopathy and diabetic macular edema. At the same time, newer therapies for the management of diabetic retinopathy have evolved. As a result of these advances, a decline in severe vision loss due to diabetes has been witnessed in some developing countries. However, there is a steady increase in the number of people affected with diabetes, and is expected to rise further in the coming years. Therefore, it is prudent to identify diabetic retinopathy, and timely intervention is needed to decrease the burden of severe vision loss. An effort has been made to review all the existing knowledge regarding diabetic retinopathy in this article and summarize the present treatment options for diabetic retinopathy.
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Affiliation(s)
- Vijender Kour
- Consultant Ophthalmology, Department of Ophthalmology, Sub District Hospital, Tral, Pulwama, India
| | - Jayshree Swain
- Department of Endocrinology, IMS and Sum Hospital, Siksha O Anusandhan (SOA) University, Bhubaneswar, India
| | - Jaspreet Singh
- Department of Endocrinology, IMS and Sum Hospital, Siksha O Anusandhan (SOA) University, Bhubaneswar, India
| | - Hershdeep Singh
- Consultant Neurosurgeon, Department of Neurosurgery, Fortis Ludhiana, Bhubaneswar, India
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Chitturi SP, Venkatesh R, Mangla R, Parmar Y, Sangoram R, Yadav NK, Chhablani J. REal-world treatment outcomes after delayed intRavitreal therapy in center-involving diabetic macular edema - RETORT study. Int J Retina Vitreous 2023; 9:22. [PMID: 36998064 DOI: 10.1186/s40942-023-00463-y] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2023] [Accepted: 03/26/2023] [Indexed: 04/01/2023] Open
Abstract
PURPOSE To compare real-life data on delayed intravitreal treatment of diabetic macular edema (DME) patients to early treatment. METHODS In this single-centre, retrospective, interventional, comparative study, DME patients were divided into two groups based on when they received treatment: Group 1 - received treatment within 24 weeks and Group 2 - at or after 24 weeks from the time of treatment advice. Visual acuity and central subfield thickness (CSFT) changes were compared at various time points. Reasons for delaying treatment were noted. RESULTS The study included 109 (Group 1-94; Group 2-15) eyes. When treatment was advised, demographic profile, diabetes duration, glucose control and VA between two groups were comparable. At this point, CSFT was higher in Group 1 than in Group 2 (p = 0.036). At injection time, Group 2 had better VA and lower CSFT than Group 1 (p < 0.05). Group 2's VA (53.4 ± 12.67) was significantly lower than Group 1's (57.38 ± 20.01) after 1-year treatment. At 1-year, CSFT decreased in Group 1 and increased in Group 2. Group 1 had mean improvement of + 7.6 letters and Group 2 had a decline of -6.9 letters. Group 2 required more intravitreal anti-VEGF (median - 3; IQR: 2-4), steroid injections (median - 4; IQR: 2-4) and focal laser sessions (median - 4; IQR: 2-4). CONCLUSION Late-treated DME eyes needed more injections and focal laser sessions than early treated eyes. Adherence to early treatment of DME in real-life will help prevent long-term vision loss.
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Affiliation(s)
- Sai Prashanti Chitturi
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Ramesh Venkatesh
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India.
| | - Rubble Mangla
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Yash Parmar
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Rohini Sangoram
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Naresh Kumar Yadav
- Dept. of Retina and Vitreous, Narayana Nethralaya, #121/C, 1st R Block, Chord Road, Rajaji Nagar, 560010, Bengaluru, Karnataka, India
| | - Jay Chhablani
- Medical Retina and Vitreoretinal Surgery, University of Pittsburgh School of Medicine, 203 Lothrop Street, Suite 800, Pittsburg, PA, 15213, USA
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Yilmaz M, Citirik M, Rahmanlar H, Alkan A, Gursoz H. Off-label uses of Aflibercept, Ranibizumab and Dexamethasone implant for diabetic retinopathy in Turkey. Rom J Ophthalmol 2022; 66:304-309. [PMID: 36589330 PMCID: PMC9773121 DOI: 10.22336/rjo.2022.56] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/03/2022] [Indexed: 12/24/2022] Open
Abstract
Objective: Diabetic retinopathy (DRP) is the most common retinal vascular disease leading to blindness. There is limited data about the off-label drug use for DRP and diabetic macular edema (DME) in literature. The aim of the article was to evaluate the applications for off-label drug use in patients with DME and DRP in Turkey in terms of demographic and clinical characteristics. Methods: Applications for off-label drug use from hospitals across Turkey to the Turkish Medicines and Medical Devices Agency for DRP in 2018 were reviewed retrospectively. Results: 112 approved applications for 167 eyes were included in our study. The mean age of the cases was 61.24 ± 10.23 years, of them 57.1% were males and 42.9% were females. Of these applications, 41.1% were for aflibercept (n:46), 33.9% for ranibizumab (n:38), and 25% for dexamethasone implant (n:28). There was no application for bevacizumab. In terms of referring hospitals, public university hospitals were in the first place with a rate of 70.5%. The most common reasons for applications were drug switchback request and failure to complete loading dose, respectively. Discussions: DRP treatment can sometimes be challenging. The effectiveness of the intravitreal drugs may decrease over time and drug switching may be necessary. In Turkey, intravitreal drugs are only approved and reimbursed for DRP patients in case of macular edema. Off-label drug use may be preferred in non-approved indications and for reasons such as the need for additional drug doses to the determined limits. However, permission must be obtained from TMMDA for off-label drug use in Turkey. Conclusion: Anti-vascular endothelial growth factor drugs are the first-line treatment options for DME. TMMDA currently approves stepwise therapy for diabetic macular edema, initiated with bevacizumab. Bevacizumab administration does not require approval for off-label application. Additionally, ranibizumab, aflibercept, and dexamethasone implant are reimbursed only in case of failure to respond to 3 doses of bevacizumab injection. Our report provides information about off-label drug preferences and drug use regulations in DRP treatment in Turkey. Abbreviations:DME = diabetic macular edema, DRP = Diabetic retinopathy, FFA = fundus fluorescein angiography, TMMDA = Turkish Medicines and Medical Devices Agency, VEGF = vascular endothelial growth factor.
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Affiliation(s)
- Mevlut Yilmaz
- Department of Ophthalmology, University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital, Ankara, Turkey
| | - Mehmet Citirik
- Department of Ophthalmology, University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital, Ankara, Turkey
| | - Hanife Rahmanlar
- Turkish Medicines and Medical Devices Agency, Turkish Ministry of Health, Ankara, Turkey
| | - Ali Alkan
- Turkish Medicines and Medical Devices Agency, Turkish Ministry of Health, Ankara, Turkey
| | - Hakki Gursoz
- Turkish Medicines and Medical Devices Agency, Turkish Ministry of Health, Ankara, Turkey
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