关键词: Anti-VEGF diabetic macular edema intravitreal injection real-life study routine clinical practice

Mesh : Humans Macular Edema / diagnosis drug therapy etiology Diabetic Retinopathy / complications diagnosis drug therapy Endothelial Growth Factors / therapeutic use Dexamethasone Retrospective Studies Turkey Diabetes Mellitus / drug therapy Randomized Controlled Trials as Topic

来  源:   DOI:10.4274/tjo.galenos.2023.56249   PDF(Pubmed)

Abstract:
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要:
本研究旨在报告玻璃体腔注射(IVI)抗血管内皮生长因子(抗VEGF)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,并概述在Türkiye的常规临床实践中的结果。
这次回顾展,真实世界的研究纳入了来自Türkiye马尔马拉地区亚洲一侧8家三级诊所的21名眼科医生(MARMASIA研究组)的1,372眼(854例患者),接受了prorenata方案治疗.通过收集患者的基线和3、6、12、24和36个月的随访数据,建立了五个队列组。其中每个后续群组可以包括先前的。最佳矫正视力的变化(BCVA,近似ETDRS字母)和中央黄斑厚度(CMT,μm),访问次数和IVI,评估了抗VEGF开关和玻璃体内注射地塞米松(IDI)组合的发生率。
3、6、12、24和36个月的队列包括1372(854),1352(838),1185(722),972(581),和623(361)眼(患者),分别。平均基线BCVA和CMT分别为51.4±21.4个字母和482.6±180.3μm。BCVA相对于基线的平均变化为+7.6、+9.1、+8.0、+8.6和+8.4字母,在3、6、12、24和36个月的随访中,CMT分别为-115.4、-140.0、-147.9、-167.3和-215.4μm(均p<0.001)。抗VEGFIVI的中位累积数量分别为3.0、3.0、5.0、7.0和9.0。总的抗VEGF转换和IDI组合率分别为18.5%(253/1372眼)和35.0%(480/1372眼),分别。
这项来自Türkiye的DME的最大的现实生活研究表明,BCVA的收益不如随机对照试验,主要是由于IVI数量较少。然而,在我们的队列中,较低的基线BCVA和较高的IDI组合率,这些收益相对优于其他现实生活中的研究同行。
公众号