Palmetto Retina Center, West Columbia, South Carolina.
Retina-Vitreous Associates Medical Group, Beverly Hills, California.
Ophthalmology. 2016 Feb;123(2):330-336. doi: 10.1016/j.ophtha.2015.09.035. Epub 2015 Oct 30.
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.
VIBRANT was a double-masked, randomized, phase 3 trial.
Eyes randomized and treated in VIBRANT were followed to week 52.
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).
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.
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 μm versus 128.0 μm (P < 0.0001) at week 24 and 283.9 μm versus 249.3 μm (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.
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.
比较 2 毫克玻璃体内阿柏西普注射（IAI）与格栅激光治疗视网膜分支静脉阻塞（BRVO）后黄斑水肿的第 52 周疗效和安全性。
VIBRANT 是一项双盲、随机、3 期临床试验。
在 VIBRANT 中随机治疗的眼睛随访至第 52 周。
IAI 组的眼睛在第 24 周前每 4 周接受 IAI 治疗，在第 24 周后每 8 周接受 IAI 治疗，如果第 36 周需要，可进行格栅激光抢救。在格栅激光组中，所有眼睛在基线时接受格栅激光治疗，如果符合预设的抢救标准，从第 12 周到第 20 周，每 3 个月剂量后加用 1 次激光治疗（激光/IAI 组）。
主要观察指标为第 24 周时最佳矫正视力（BCVA）字母评分较基线提高≥15 的眼睛比例。第 52 周的所有观察指标均为探索性指标，P 值视为名义值。
IAI 组和激光/IAI 组中，第 24 周时较基线 BCVA 字母评分提高≥15 的眼睛比例分别为 52.7%和 26.7%（P = 0.0003），第 52 周时分别为 57.1%和 41.1%（P = 0.0296）。相应的从基线 BCVA 字母评分的平均变化分别为 17.0 和 6.9（P < 0.0001），第 24 周和 17.1 和 12.2（P = 0.0035），第 52 周。从基线中央视网膜厚度的平均减少分别为 280.5μm 和 128.0μm（P < 0.0001），第 24 周和 283.9μm 和 249.3μm（P = 0.0218），第 52 周。IAI 组中有 10.6%的眼睛在第 36 周接受了抢救性激光治疗，激光/IAI 组中有 80.7%的眼睛从第 24 周到第 48 周接受了抢救性 IAI 治疗。IAI 组中有 1 只眼睛（1.1%）发生外伤性白内障，为唯一眼部严重不良事件。
6 个月 IAI 后，每 8 周注射一次可维持黄斑水肿和视力获益至第 52 周。在激光组中，从第 24 周开始使用抢救性 IAI 可使第 52 周的视力显著改善。
