Ranibizumab or Aflibercept for Diabetic Macular Edema Comparison of 1-Year Outcomes from the Fight Retinal Blindness! Registry
Ranibizumab or Aflibercept for Diabetic Macular Edema Comparison of 1-Year Outcomes from the Fight Retinal Blindness! Registry
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DOI：
10.1016/j.ophtha.2019.11.018
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发表时间：
2020-05-01
期刊：
影响因子：
13.7
通讯作者：
Barthelmes, Daniel
中科院分区：
文献类型：
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作者：
Bhandari, Sanjeeb;Nguyen, Vuong;Barthelmes, Daniel
目的：在临床试验中，雷珠单抗和阿柏西普都能改善糖尿病性黄斑水肿（DME）患者的视力并降低黄斑厚度。本研究比较了12个月的治疗结果，每种药物在常规临床practice.Design：回顾性分析的数据，从前瞻性设计的观察战斗视网膜盲！registry.Participants:在登记研究中跟踪的首次接受雷珠单抗治疗的眼睛2013年12月1日至2018年6月1日期间，对所有患眼进行了12个月时的视力（VA）分析。（完成者、未完成者和转换治疗的眼睛）。主要结果测量：主要结果是VA从基线到12 months.Results的平均变化：我们确定了291例患者的383只眼（雷珠单抗，n = 166只眼;阿柏西普，n = 217只眼）。与接受雷珠单抗的眼睛相比，接受阿柏西普的眼睛在基线时显示出较低的平均VA（平均差异，-3.1个字母）和较厚的黄斑（平均差异，+26 μ m），两者无显著差异。接受雷珠单抗治疗的患者年龄较大（平均差异为+2.7岁）。VA变化和中央视野厚度（CST）减少的校正平均差异分别为+1个字母（阿柏西普为1.4个字母，雷珠单抗为0.4个字母; P = 0.4）和-30 μ m（-85 vs. -55 μ m; P < 0.01），初始视力为20/40或更好且+3个字母VA为20/50或更差的患者中，-46 μ m（-148 vs. -102 μ m; P < 0.02）。阿柏西普组的眼睛在12个月内接受的中位注射次数比雷珠单抗组多，尽管这种差异不显著（8次vs. 6次注射; P = 0.13）。治疗转换，虽然低，从雷珠单抗到阿柏西普比反之亦然更频繁。在12个月内，aflibercept组有更多的眼睛失访（21% vs. 9% ranibizumab; P < 0.01）。接受阿柏西普治疗的眼睛在基线时视力较差，黄斑较厚，在治疗12个月后CST下降幅度较大。当初始VA为20/50或更差时，使用阿柏西普治疗观察到较大的VA增益。(C)2019年美国眼科学会
Purpose: Both ranibizumab and aflibercept improved vision and decreased macular thickness in eyes with diabetic macular edema (DME) in clinical trials. This study compared the 12-month treatment outcomes of each drug in routine clinical practice.Design: Retrospective analysis of data from the prospectively designed observational Fight Retinal Blindness! registry.Participants: Treatment-naive eyes tracked in the registry that initiated treatment with either ranibizumab (0.5 mg) or aflibercept (2 mg) for DME from December 1, 2013, through June 1, 2018.Methods: Visual acuity (VA) was analyzed at 12 months in all eyes (completers, noncompleters, and eyes that switched treatment).Main Outcome Measures: The primary outcome was the mean change in VA from baseline to 12 months.Results: We identified 383 eyes (ranibizumab, n = 166 eyes; aflibercept, n = 217 eyes) of 291 patients. Eyes receiving aflibercept showed a lower mean VA (mean difference, -3.1 letters) and a thicker maculae (mean difference, +26 mu m) at baseline than those receiving ranibizumab, which were not significantly different. Patients receiving ranibizumab were older (mean difference, +2.7 years). The adjusted mean difference in VA change and central subfield thickness (CST) reduction were, respectively, +1 letter (1.4 letters for aflibercept vs. 0.4 letter for ranibizumab; P = 0.4) and -30 mu m (-85 vs. -55 mu m; P < 0.01) in eyes with initial VA of 20/40 or better and +3 letters (10.6 vs. 7.6 letters; P < 0.01) and -46 mu m (-148 vs. -102 mu m; P < 0.02) in those with VA of 20/50 or worse. Eyes in the aflibercept group received more median injections over 12 months than the ranibizumab group although this difference was not significant (8 vs. 6 injections; P = 0.13). Treatment switches, albeit low, were more frequent from ranibizumab to aflibercept than vice versa. Significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% vs. 9% ranibizumab; P < 0.01).Conclusions: Both drugs were beneficial for DME. Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, showed larger CST reductions after 12 months of treatment. Larger VA gains were observed with aflibercept treatment when the initial VA was 20/50 or worse. (C) 2019 by the American Academy of Ophthalmology