Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion 52-Week Results of the VIBRANT Study
Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion 52-Week Results of the VIBRANT Study
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DOI：
10.1016/j.ophtha.2015.09.035
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发表时间：
2016-02-01
期刊：
影响因子：
13.7
通讯作者：
Campochiaro, Peter A.
中科院分区：
文献类型：
--
作者：
Clark, W. Lloyd;Boyer, David S.;Campochiaro, Peter A.
目的：确定与网格激光相比，2 mg 玻璃体内阿柏西普注射 (IAI) 治疗视网膜分支静脉阻塞 (BRVO) 后出现黄斑水肿的眼睛在第 52 周的疗效和安全性结果。设计：VIBRANT 是一项双盲、随机、3 期试验。参与者：随机接受 VIBRANT 治疗的眼睛随访至第 52 周。方法：在 IAI 组中，眼睛每 4 周接受一次 IAI第 24 周至第 48 周每 8 周进行一次 IAI，如果需要，在第 36 周时使用救援网格激光。在网格激光组中，所有眼睛在基线时接受网格激光，如果满足预先指定的救援标准，则从第 12 周至第 20 周额外进行 1 次激光，从第 24 周开始，在 3 个月剂量后每 8 周进行 IAI（激光/IAI 组）。 主要结果测量：主要结果测量是较基线最佳校正有所改善的眼睛的百分比第 24 周时视力 (BCVA) 字母评分 >= 15。第 52 周时的所有结果测量均为探索性的，P 值被视为名义值。结果：IAI 组和激光/IAI 组中相对于基线字母评分 >= 15 有所改善的眼睛百分比在第 24 周时分别为 52.7% 和 26.7% (P = 0.0003)，在第 24 周分别为 57.1% 和 41.1% (P =第 52 周时，BCVA 字母评分相对于基线的平均变化为 17.0 与 6.9 (P < 0.0001)；第 52 周时，相对于基线的平均变化分别为 17.0 与 6.9 (P < 0.0001)；第 52 周时，相对于基线的平均变化分别为 17.1 与 12.2 (P = 0.0035)。中央视网膜厚度与基线的平均减少分别为 280.5 mm 与 128.0 mm (P < 0.0001)第 24 周时为 283.9 mm，第 52 周时为 249.3 mm (P = 0.0218)。在 IAI 组中，10.6% 的眼睛在第 36 周时接受了救援激光治疗，而在激光/IAI 组中，80.7% 的眼睛在第 24 周至第 48 周期间接受了救援 IAI。IAI 组中有 1 只眼睛 (1.1%) 出现外伤性白内障，这是唯一严重的眼部严重并发症。结论：6 个月 IAI 后，每 8 周注射一次，可维持对黄斑水肿的控制，并在第 52 周保持视力改善。在激光组中，从第 24 周开始进行救援 IAI 导致第 52 周时视力显着改善。(C) 2016，美国眼科学会。
Purpose: To determine week 52 efficacy and safety outcomes in eyes with macular edema after branch retinal vein occlusion (BRVO) treated with 2 mg intravitreal aflibercept injection (IAI) compared with grid laser.Design: VIBRANT was a double-masked, randomized, phase 3 trial.Participants: Eyes randomized and treated in VIBRANT were followed to week 52.Methods: In the IAI group, eyes received IAI every 4 weeks through week 24 and IAI every 8 weeks through week 48 with rescue grid laser if needed at week 36. In the grid laser group, all eyes received grid laser at baseline and, if prespecified rescue criteria were met, 1 additional laser from week 12 to 20 and IAI every 8 weeks after 3 monthly doses from week 24 onward (the laser/IAI group).Main Outcome Measures: The primary outcome measure was percentage of eyes with improvement from baseline best-corrected visual acuity (BCVA) letter score >= 15 at week 24. All outcome measures at week 52 were exploratory, and P values are considered nominal.Results: The percentage of eyes with improvement from baseline letter score >= 15 in the IAI and laser/IAI groups was 52.7% versus 26.7% (P = 0.0003) at week 24 and 57.1% versus 41.1% (P = 0.0296) at week 52. The corresponding mean change from baseline BCVA letter score was 17.0 versus 6.9 (P < 0.0001) at week 24 and 17.1 versus 12.2 (P = 0.0035) at week 52. The mean reduction from baseline central retinal thickness was 280.5 mm versus 128.0 mm (P < 0.0001) at week 24 and 283.9 mm versus 249.3 mm (P = 0.0218) at week 52. In the IAI group, 10.6% of eyes received rescue laser at week 36, and in the laser/IAI group, 80.7% received rescue IAI from week 24 to week 48. Traumatic cataract in 1 eye (1.1%) in the IAI group was the only ocular serious adverse event.Conclusions: After 6 monthly IAI, injections every 8 weeks maintained control of macular edema and visual benefits through week 52. In the laser group, rescue IAI given from week 24 onward resulted in substantial visual improvements at week 52. (C) 2016 by the American Academy of Ophthalmology.