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. Methods 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. Results 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). Conclusion 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. Data are not publicly available. The statistical analysis plan can be obtained by request.

中文翻译：

---

雷珠单抗与阿柏西普治疗视网膜分支静脉阻塞黄斑水肿的 12 个月结果：来自 FRB 的数据！登记处

背景/目的比较雷珠单抗（0.5 mg）和阿柏西普（2 mg）治疗视网膜分支静脉阻塞（BRVO）引起的黄斑囊样水肿超过12个月的疗效。方法 一项多中心、国际、数据库观察研究招募了 322 只眼睛在 5 年的实际实践中开始治疗。主要结果测量是视力 (VA) 的 EDTRS 字母评分的平均变化。次要结果包括解剖结果、VA > 6/12（70 个字母）的眼睛百分比、注射和就诊次数、首次不活动时间、转换或未完成。结果 广义混合效应模型表明，雷珠单抗和阿柏西普的平均 (95% CI) 调整后 12 个月 VA 变化相似（分别为 +10.8（8.2 至 13.4）和 +10.9（8.3 至 13.5）个字母，p=0.59）。阿柏西普的中心亚区厚度 (CST) 的平均调整变化大于雷珠单抗（分别为 -170（-153 至 –187）μm 与 -147（-130 至 –164）μm，p=0.001）。治疗组之间 7 (4, 8) 次注射和 9 (7, 11) 次就诊的总体中位数 (Q1, Q3) 相似。阿柏西普的第一次不活动分级发生得更快（p = 0.01）。雷珠单抗（37 只眼，23%）比阿柏西普（17 只眼，11%；p=0.002）更常见。结论 雷珠单抗和阿柏西普在实际实践中直接比较 BRVO 的 12 个月时的视觉结果总体上是良好的，并且这两种药物相似，尽管阿柏西普对 CST 的影响更大，并且到第一次不活动分级的时间。数据不公开。统计分析方案可按要求索取。