Centre for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia; Department of Ophthalmology, Royal Perth Hospital, Perth, Australia.
Centre for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia; Department of Ophthalmology, Royal Perth Hospital, Perth, Australia.
Am J Ophthalmol. 2014 Jan;157(1):237-247.e1. doi: 10.1016/j.ajo.2013.08.013. Epub 2013 Oct 7.
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.
A prospective randomized controlled clinical trial.
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.
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 μm vs 175.6 μm, 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.
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.
评估玻璃体腔注射 0.5mg 雷珠单抗治疗视网膜分支静脉阻塞（BRVO）引起的黄斑水肿的疗效，为期 1 年，与标准护理格栅激光相比。
前瞻性随机对照临床试验。
从 5 家机构招募了 36 名因 BRVO 后黄斑水肿导致视力丧失的患者。患者按 1:1 随机分为治疗组和标准护理组。治疗组接受 6 次 0.5mg 雷珠单抗注射，之后每月根据最佳矫正视力（BCVA）和光学相干断层扫描（OCT）的中央视网膜厚度（CFT）评估结果按需注射，标准护理组在研究期间接受 1 年的每月假注射。如果符合激光治疗标准，则在两组中分别于 13 周和 25 周进行格栅激光治疗。主要观察指标包括从基线到 12 个月时 ETDRS 字母评分的平均 BCVA 变化。次要观察指标包括两组的解剖学结果和需要格栅激光治疗的患者比例。
治疗组从基线到 12 个月时的平均 BCVA 变化明显大于标准护理组（12.5 ETDRS 字母比-1.6 ETDRS 字母，P=0.032）。与标准护理组相比，治疗组的平均 CFT 明显降低（361.7μm比 175.6μm，P=0.025）。在 13 周和 25 周时，标准护理组（68.4%，50.0%）比治疗组（6.7%，8.3%）更多的患者接受了格栅激光治疗。未观察到新的眼部或全身不良事件。
与标准格栅激光相比，玻璃体腔注射雷珠单抗可显著提高视力，并改善 BRVO 引起的黄斑水肿患者的解剖学改善。
