Background/aims We characterised the relationships between monitoring frequency, ranibizumab injection need and vision in patients receiving as-needed (pro re nata; PRN) ranibizumab for macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in this post-hoc analysis of SHORE and HORIZON. Methods Patients aged 18 years and older with macular oedema due to BRVO/CRVO were included in this analysis. Injection frequency and best-corrected visual acuity (BCVA) were evaluated by PRN injection frequency in the PRN dosing phase (months (M) 7–15) of SHORE and through 12 months of HORIZON. Prespecified PRN re-treatment criteria for each trial were based on protocol-prespecified BCVA and optical coherence tomography outcomes. Results After the initial 7 monthly ranibizumab injections, patients in SHORE gained a mean of 18.3 letters from baseline. Patients randomised to PRN, on average, maintained these gains. However, some patients experienced additional mean gains, whereas others suffered losses (range 4.0 (95% CI 0.7 to 7.3) to −4.6 (95% CI −11.8 to 2.6) letters in patients who received 0 and 6–7 PRN injections, respectively). In BRAVO and CRUISE (lead-in trials), patients experienced mean gains from baseline to M6 (monthly dosing) of 19.3 and 15.0 letters, respectively, with gains maintained with PRN from M6 to M12. However, mean BCVA changes from baseline to M12 varied in HORIZON (range −0.4 (95% CI −2.5 to 1.6) to −3.6 (95% CI −6.2 to −1.0) letters in patients who received zero and six injections, respectively, during the preceding PRN phase of BRAVO and CRUISE). Conclusion The BRVO/CRVO population is heterogenous with a varied response to ranibizumab treatment. Data are available upon reasonable request. For eligible studies, qualified researchers may request access to individual patient-level clinical data through a data request platform. At the time of writing, this request platform is Vivli. . For up-to-date details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: [https://go.roche.com/data_sharing][1]. Anonymised records for individual patients across more than one data source external to Roche cannot, and should not, be linked due to a potential increase in risk of patient re-identification. [1]: https://www.roche.com/innovation/process/clinical-trials/data-sharing

中文翻译：

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视网膜静脉阻塞患者疾病活动度、治疗频率和视力结局的异质性：按需使用雷珠单抗注射需求与视力之间的关系


背景/目的 我们描述了按需接受 （pro re nata;PRN） 雷珠单抗治疗由于视网膜分支静脉阻塞 （BRVO） 或视网膜中央静脉阻塞 （CRVO） 引起的黄斑水肿，在 SHORE 和 HORIZON 的事后分析中。方法 纳入 18 岁及以上因 BRVO/CRVO 导致黄斑水肿的患者。在 SHORE 的 PRN 给药阶段（个月 （M） 7-15 个月）和 HORIZON 的 12 个月中，通过 PRN 注射频率评估注射频率和最佳矫正视力 （BCVA）。每项试验的预先指定的 PRN 再治疗标准基于方案预先指定的 BCVA 和光学相干断层扫描结果。结果 在最初 7 个月一次雷珠单抗注射后，SHORE 患者从基线平均增加了 18.3 个字母。平均而言，随机分配到 PRN 组的患者保持了这些收益。然而，一些患者经历了额外的平均收益，而另一些患者则遭受了损失（在接受 0 和 6-7 次 PRN 注射的患者中，范围分别为 4.0 （95% CI 0.7 至 7.3） 至 -4.6 （95% CI -11.8 至 2.6） 字母）。在 BRAVO 和 CRUISE （导入试验） 中，患者从基线到 M6 （每月给药） 的平均增加分别为 19.3 和 15.0 个字母，PRN 从 M6 到 M12 的增益保持不变。然而，从基线到 M12 的平均 BCVA 变化在 HORIZON 中有所不同（范围 -0.4 （95% CI -2.5 至 1.6） 至 -3.6 （95% CI -6.2 至 -1.0） 在之前的 BRAVO 和 CRUISE 的 PRN 阶段接受 0 次和 6 次注射的患者）。结论 BRVO/CRVO 人群具有异质性，对雷珠单抗治疗的反应各不相同。数据可根据合理要求提供。 对于符合条件的研究，合格的研究人员可以通过数据请求平台请求访问个体患者水平的临床数据。在撰写本文时，此请求平台为 Vivli。.有关罗氏临床信息共享全球政策以及如何请求访问相关临床研究文件的最新详细信息，请参阅此处：[https://go.roche.com/data_sharing][1]。由于 Roche 重新识别的风险可能会增加，因此不能也不应链接 Roche 外部多个数据源中单个患者的匿名记录。[1]：https://www.roche。com/innovation/process/clinical-trials/data-sharing