Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion The 24-Week Results of the VIBRANT Study
Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion The 24-Week Results of the VIBRANT Study
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DOI：
10.1016/j.ophtha.2014.08.031
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发表时间：
2015-03-01
期刊：
影响因子：
13.7
通讯作者：
Haller, Julia A.
中科院分区：
文献类型：
--
作者：
Campochiaro, Peter A.;Clark, W. Lloyd;Haller, Julia A.
目的：比较玻璃体内注射阿布西普（IAI）与黄斑网格激光光凝治疗视网膜分支静脉闭塞（BRVO）后黄斑水肿的疗效和安全性。设计：该研究是一项双盲、主动对照、随机III期试验。受试者：BRVO术后黄斑水肿的未接受治疗的眼睛，如果闭塞在12个月内发生，最佳矫正视力（BCVA）在24个早期治疗糖尿病视网膜病变研究（ETDRS）字母（20/40-20/320 Snellen当量）之间，则纳入研究。方法：从基线到第20周，每4周（n - 91）接受IAI 2mg治疗（每只眼睛1只），或在基线接受网格激光治疗（n = 92），如果需要，从第12周到第20周进行单网格激光挽救治疗。主要结局指标：主要结局指标是第24周时从基线BCVA获得>= 15 ETDRS字母的眼睛比例。次要终点包括24周时基线BCVA和中央视网膜厚度（CRT）的平均变化。结果：第24周，IAI组获得>= 15 ETDRS字母的眼睛比例为52.7%，而激光组为26.7% （P = 0.0003）。第24周时，IAI组较基线BCVA的平均改善为17.0 ETDRS字母，激光组为6.9 ETDRS字母(P
Purpose: To compare the efficacy and safety of intravitreal aflibercept injection (IAI) with macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion (BRVO).Design: The VIBRANT study was a double-masked, active-controlled, randomized, phase III trial.Participants: Treatment-naive eyes with macular edema after BRVO were included in the study if the occlusion occurred within 12 months and best-corrected visual acuity (BCVA) was between = 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/40-20/320 Snellen equivalent).Methods: Eyes (1 eye per patient) received either IAI 2 mg every 4 weeks (n - 91) from baseline to week 20 or grid laser (n = 92) at baseline with a single grid laser rescue treatment, if needed, from weeks 12 through 20.Main Outcome Measures: The primary outcome measure was the proportion of eyes that gained >= 15 ETDRS letters from baseline BCVA at week 24. Secondary end points included mean change from baseline BCVA and central retinal thickness (CRT) at week 24.Results: The proportion of eyes that gained >= 15 ETDRS letters from baseline at week 24 was 52.7% in the IAI group compared with 26.7% in the laser group (P = 0.0003). The mean improvement from baseline BCVA at week 24 was 17.0 ETDRS letters in the IAI group and 6.9 ETDRS letters in the laser group (P