Medical Retina, Westmead Hospital, Westmead, New South Wales, Australia
Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia.
Br J Ophthalmol. 2022 Aug;106(8):1178-1184. doi: 10.1136/bjophthalmol-2020-318491. Epub 2021 Mar 12.
BACKGROUND/AIMS: To compare the efficacy of ranibizumab (0.5 mg) with aflibercept (2 mg) in the treatment of cystoid macular oedema due to branch retinal vein occlusion (BRVO) over 12 months.
A multicentre, international, database observational study recruited 322 eyes initiating therapy in real-world practice over 5 years. The main outcome measure was mean change in EDTRS letter scores of visual acuity (VA). Secondary outcomes included anatomic outcomes, percentage of eyes with VA >6/12 (70 letters), number of injections and visits, time to first inactivity, switching or non-completion.
Generalised mixed effect models demonstrated that mean (95% CI) adjusted 12-month VA changes for ranibizumab and aflibercept were similar (+10.8 (8.2 to 13.4) vs +10.9 (8.3 to 13.5) letters, respectively, p=0.59). The mean adjusted change in central subfield thickness (CST) was greater for aflibercept than ranibizumab (-170 (-153 to -187) µm vs -147 (-130 to -164) µm, respectively, p=0.001). The overall median (Q1, Q3) of 7 (4, 8) injections and 9 (7, 11) visits was similar between treatment groups. First grading of inactivity occurred sooner with aflibercept (p=0.01). Switching was more common from ranibizumab (37 eyes, 23%) than from aflibercept (17 eyes, 11%; p=0.002).
Visual outcomes at 12 months in this direct comparison of ranibizumab and aflibercept for BRVO in real-world practice were generally good and similar for the 2 drugs, despite a greater effect of aflibercept on CST and time to first grading of inactivity.
背景/目的：比较雷珠单抗（0.5mg）与阿柏西普（2mg）在治疗分支静脉阻塞（BRVO）引起的黄斑囊样水肿（CME）方面的疗效，随访时间为 12 个月。
一项多中心、国际数据库观察性研究，在 5 年内共招募了 322 只接受治疗的眼。主要观察指标是最佳矫正视力（BCVA）的平均变化（EDTRS 字母评分）。次要观察指标包括解剖学结果、BCVA>6/12（70 个字母）的眼比例、注射次数和访视次数、首次无活动期、转换或未完成时间。
广义混合效应模型显示，雷珠单抗和阿柏西普治疗后 12 个月的平均（95%可信区间）调整后视力变化相似（+10.8（8.2 至 13.4）与+10.9（8.3 至 13.5）个字母，p=0.59）。阿柏西普组中央视网膜神经纤维层厚度（CST）的平均调整后变化大于雷珠单抗组（-170（-153 至-187）µm 与-147（-130 至-164）µm，p=0.001）。两组治疗的总中位数（Q1，Q3）为 7（4，8）次注射和 9（7，11）次访视。阿柏西普组首次无活动期的评分较早（p=0.01）。从雷珠单抗转换为其他药物的情况更为常见（37 只眼，23%），而从阿柏西普转换的情况较少（17 只眼，11%；p=0.002）。
本项在真实世界环境中直接比较雷珠单抗和阿柏西普治疗 BRVO 的研究中，12 个月时的视力结果总体较好，两种药物的结果相似，尽管阿柏西普对 CST 和首次无活动期评分的影响更大。
