Randomized Controlled Trial of Intravitreal Ranibizumab Versus Standard Grid Laser for Macular Edema Following Branch Retinal Vein Occlusion
Randomized Controlled Trial of Intravitreal Ranibizumab Versus Standard Grid Laser for Macular Edema Following Branch Retinal Vein Occlusion
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DOI：
10.1016/j.ajo.2013.08.013
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发表时间：
2014-01-01
影响因子：
4.2
通讯作者：
Wong, Tien Y.
中科院分区：
文献类型：
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作者：
Tan, Mei Hong;Mcallister, Ian L.;Wong, Tien Y.
目的：与标准治疗网格激光相比，评估0.5 mg雷尼单抗玻璃体内注射治疗1年以上视网膜分支静脉闭塞（BRVO）继发性黄斑水肿的疗效。设计：前瞻性随机对照临床试验。方法：从5家机构招募BRVO术后黄斑水肿致单眼视力丧失患者36例。患者以1:1的比例随机分配到治疗组，治疗组每月接受6次0.5 mg雷尼珠单抗注射，之后根据光学相干断层扫描的最佳矫正视力（BCVA）和中央中央窝厚度（CFT）评估每月接受0.5 mg雷尼珠单抗注射，或标准护理组，在1年的研究期间每月接受假注射。如果满足激光治疗标准，两组分别在13周和25周进行网格激光治疗。主要结局指标包括早期治疗糖尿病视网膜病变研究（ETDRS）中BCVA评分从基线到第12个月的平均变化。次要结果包括解剖结果和两组需要网格激光治疗的患者百分比。结果：与标准护理组相比，治疗组在12个月时的BCVA平均变化明显大于基线（12.5 ETDRS字母vs -1.6 ETDRS字母，P = 0.032）。与标准护理组相比，治疗组的平均CFT显著降低（361.7 μ m vs 175.6 μ m, P = 0.025）。在13周和25周时，标准护理组接受网格激光治疗的患者（68.4%,50.0%）多于治疗组（6.7%,8.3%）。未观察到新的眼部或全身不良事件。结论：与标准网格激光相比，玻璃体内雷尼单抗在BRVO继发黄斑水肿患者的视力增加和解剖改善方面提供了显著和持续的益处。(C) Elsevier Inc. 2014。版权所有。)
PURPOSE: To assess the efficacy of intravitreal 0.5 mg ranibizumab for the treatment of center-involving macular edema secondary to branch retinal vein occlusion (BRVO) over 1 year compared with standard-of-care grid laser.DESIGN: A prospective randomized controlled clinical trial.METHODS: A total of 36 patients with vision loss in 1 eye attributable to macular edema following BRVO were recruited from 5 institutions. Patients were randomized 1:1 to a treatment group that received 6 monthly injections of 0.5 mg ranibizumab and thereafter monthly as needed based on best-corrected visual acuity (BCVA) and central foveal thickness (CFT) assessments on optical coherence tomography scans, or a standard-of-care group that received monthly sham injections for the 1-year duration of the study. Grid laser was administered at 13 and 25 weeks in both groups if criteria for laser treatment were met. Main outcome measures included mean change in BCVA in Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores from baseline to month 12. Secondary outcomes included anatomic outcomes and the percentage of patients requiring grid laser in both groups.RESULTS: Mean BCVA change from baseline was significantly greater in the treatment compared with the standard-of-care group at 12 months (12.5 ETDRS letters vs -1.6 ETDRS letters, P = .032). The mean CFT was significantly reduced in the treatment compared with standard-of-care group (361.7 mu m vs 175.6 mu m, P = .025). At 13 and 25 weeks, more patients in the standard-of-care group (68.4%, 50.0%) received grid laser than in the treatment group (6.7%, 8.3%). No new ocular or systemic adverse events were observed.CONCLUSIONS: Compared with standard grid laser, intravitreal ranibizumab provided significant and sustained benefits in visual acuity gain and anatomic improvement in eyes with macular edema secondary to BRVO. ((C) 2014 by Elsevier Inc. All rights reserved.)