Real-World Outcomes of Intravitreal Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in Türkiye: MARMASIA Study Group Report No. 1.

Q3 Medicine

Turkish Journal of Ophthalmology Pub Date : 2023-12-21 DOI:10.4274/tjo.galenos.2023.56249

Uğur Yayla, Mehmet Orkun Sevik, Veysel Levent Karabaş, Özlem Şahin, Abdullah Özkaya, Nursal Melda Yenerel, Banu Açıkalın Öncel, Fatih Bilgehan Kaplan, Ecem Önder Tokuç, Hatice Selen Kanar, Işıl Kutlutürk Karagöz, Ece Başaran Emengen, Ayşe Demirciler Sönmez, Aslan Aykut, Utku Limon, Erdinç Bozkurt, Işılay Özsoy Saygın, Tuğba Aydoğan Gezginaslan, Özlem Aydın Öncü, Esra Türkseven Kumral, Nimet Yeşim Erçalık, Erkan Çelik

{"title":"Real-World Outcomes of Intravitreal Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in Türkiye: MARMASIA Study Group Report No. 1.","authors":"Uğur Yayla, Mehmet Orkun Sevik, Veysel Levent Karabaş, Özlem Şahin, Abdullah Özkaya, Nursal Melda Yenerel, Banu Açıkalın Öncel, Fatih Bilgehan Kaplan, Ecem Önder Tokuç, Hatice Selen Kanar, Işıl Kutlutürk Karagöz, Ece Başaran Emengen, Ayşe Demirciler Sönmez, Aslan Aykut, Utku Limon, Erdinç Bozkurt, Işılay Özsoy Saygın, Tuğba Aydoğan Gezginaslan, Özlem Aydın Öncü, Esra Türkseven Kumral, Nimet Yeşim Erçalık, Erkan Çelik","doi":"10.4274/tjo.galenos.2023.56249","DOIUrl":null,"url":null,"abstract":"Objectives: This study aimed to report the demographic and clinical characteristics of diabetic macular edema (DME) patients treated with intravitreal injection (IVI) of anti-vascular endothelial growth factors (anti-VEGF) and provide an overview of outcomes during routine clinical practice in Türkiye.Materials and methods: This retrospective, real-world study included 1,372 eyes (854 patients) treated with a pro re nata protocol by 21 ophthalmologists from 8 tertiary clinics on the Asian side of the Marmara region of Türkiye (MARMASIA Study Group). Five cohort groups were established by collecting the patients' baseline and 3, 6, 12, 24, and 36-month follow-up data, where each subsequent cohort may include the previous. Changes in best-corrected visual acuity (BCVA, approximate ETDRS letters) and central macular thickness (CMT, μm), number of visits and IVI, and rates of anti-VEGF switch and intravitreal dexamethasone implant (IDI) combination were evaluated.Results: The 3, 6, 12, 24, and 36-month cohorts included 1372 (854), 1352 (838), 1185 (722), 972 (581), and 623 (361) eyes (patients), respectively. The mean baseline BCVA and CMT were 51.4±21.4 letters and 482.6±180.3 μm. The mean changes from baseline in BCVA were +7.6, +9.1, +8.0, +8.6, and +8.4 letters, and in CMT were -115.4, -140.0, -147.9, -167.3, and -215.4 μm at the 3, 6, 12, 24, and 36-month visits (p<0.001 for all). The median cumulative number of anti-VEGF IVI was 3.0, 3.0, 5.0, 7.0, and 9.0, respectively. The overall anti-VEGF switch and IDI combination rates were 18.5% (253/1372 eyes) and 35.0% (480/1372 eyes), respectively.Conclusion: This largest real-life study of DME from Türkiye demonstrated BCVA gains inferior to randomized controlled trials, mainly due to the lower number of IVI. However, with the lower baseline BCVA and higher IDI combination rates in our cohorts, these gains were relatively superior to other real-life study counterparts.","PeriodicalId":23373,"journal":{"name":"Turkish Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10750085/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Turkish Journal of Ophthalmology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4274/tjo.galenos.2023.56249","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives: This study aimed to report the demographic and clinical characteristics of diabetic macular edema (DME) patients treated with intravitreal injection (IVI) of anti-vascular endothelial growth factors (anti-VEGF) and provide an overview of outcomes during routine clinical practice in Türkiye.

Materials and methods: This retrospective, real-world study included 1,372 eyes (854 patients) treated with a pro re nata protocol by 21 ophthalmologists from 8 tertiary clinics on the Asian side of the Marmara region of Türkiye (MARMASIA Study Group). Five cohort groups were established by collecting the patients' baseline and 3, 6, 12, 24, and 36-month follow-up data, where each subsequent cohort may include the previous. Changes in best-corrected visual acuity (BCVA, approximate ETDRS letters) and central macular thickness (CMT, μm), number of visits and IVI, and rates of anti-VEGF switch and intravitreal dexamethasone implant (IDI) combination were evaluated.

Results: The 3, 6, 12, 24, and 36-month cohorts included 1372 (854), 1352 (838), 1185 (722), 972 (581), and 623 (361) eyes (patients), respectively. The mean baseline BCVA and CMT were 51.4±21.4 letters and 482.6±180.3 μm. The mean changes from baseline in BCVA were +7.6, +9.1, +8.0, +8.6, and +8.4 letters, and in CMT were -115.4, -140.0, -147.9, -167.3, and -215.4 μm at the 3, 6, 12, 24, and 36-month visits (p<0.001 for all). The median cumulative number of anti-VEGF IVI was 3.0, 3.0, 5.0, 7.0, and 9.0, respectively. The overall anti-VEGF switch and IDI combination rates were 18.5% (253/1372 eyes) and 35.0% (480/1372 eyes), respectively.

Conclusion: This largest real-life study of DME from Türkiye demonstrated BCVA gains inferior to randomized controlled trials, mainly due to the lower number of IVI. However, with the lower baseline BCVA and higher IDI combination rates in our cohorts, these gains were relatively superior to other real-life study counterparts.

查看原文本刊更多论文

土耳其玻璃体内抗血管内皮生长因子治疗糖尿病黄斑水肿的实际结果:MARMASIA研究组报告1号

研究目的本研究旨在报告接受抗血管内皮生长因子（anti-VEGF）玻璃体内注射（IVI）治疗的糖尿病性黄斑水肿（DME）患者的人口统计学和临床特征，并概述土耳其常规临床实践的结果：这项回顾性真实世界研究包括来自土耳其马尔马拉地区亚洲一侧 8 家三级诊所（MARMASIA 研究小组）的 21 位眼科医生按照原方案治疗的 1372 只眼睛（854 位患者）。通过收集患者的基线数据以及 3、6、12、24 和 36 个月的随访数据，建立了五个队列组，其中每个后续队列组可包括前一个队列组。对最佳矫正视力（BCVA，近似ETDRS字母）和黄斑中心厚度（CMT，μm）的变化、就诊次数和IVI、抗血管内皮生长因子转换率和玻璃体内地塞米松植入剂（IDI）联合使用率进行评估：为期 3、6、12、24 和 36 个月的队列分别包括 1372（854）、1352（838）、1185（722）、972（581）和 623（361）只眼睛（患者）。基线 BCVA 和 CMT 的平均值分别为 51.4±21.4 个字母和 482.6±180.3 μm。在3、6、12、24和36个月的回访中，BCVA和CMT与基线相比的平均变化分别为+7.6、+9.1、+8.0、+8.6和+8.4个字母和-115.4、-140.0、-147.9、-167.3和-215.4 μm（p结论：这项土耳其最大规模的 DME 真实研究显示，BCVA 的改善程度不如随机对照试验，主要原因是 IVI 的数量较少。然而，由于我们队列中的基线BCVA较低，IDI合并率较高，这些收益相对优于其他真实生活中的同行研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Turkish Journal of Ophthalmology Medicine-Ophthalmology

CiteScore

2.20

自引率

0.00%

发文量

期刊介绍： The Turkish Journal of Ophthalmology (TJO) is the only scientific periodical publication of the Turkish Ophthalmological Association and has been published since January 1929. In its early years, the journal was published in Turkish and French. Although there were temporary interruptions in the publication of the journal due to various challenges, the Turkish Journal of Ophthalmology has been published continually from 1971 to the present. The target audience includes specialists and physicians in training in ophthalmology in all relevant disciplines.