University of California, San Francisco School of Medicine, San Francisco, California, USA
The Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Br J Ophthalmol. 2024 Aug 22;108(9):1216-1225. doi: 10.1136/bjo-2022-323120.
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.
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.
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).
The BRVO/CRVO population is heterogenous with a varied response to ranibizumab treatment.
背景/目的：我们对 SHORE 和 HORIZON 试验中接受按需（即需即给；PRN）雷珠单抗治疗的视网膜分支静脉阻塞（BRVO）或视网膜中央静脉阻塞（CRVO）患者的监测频率、雷珠单抗注射需求与视力之间的关系进行了特征描述。
本分析纳入了 BRVO/CRVO 所致黄斑水肿患者，年龄 18 岁及以上。在 SHORE 的 PRN 给药阶段（第 7-15 个月）和 HORIZON 的 12 个月期间，根据 PRN 注射频率评估注射频率和最佳矫正视力（BCVA）。两个试验的 PRN 再治疗标准均基于方案预设的 BCVA 和光学相干断层扫描（OCT）结果。
在最初的 7 次雷珠单抗注射后，SHORE 中的患者平均从基线增加了 18.3 个字母。平均而言，随机接受 PRN 治疗的患者保持了这些改善。然而，一些患者有进一步的平均改善，而另一些患者则有损失（分别接受 0 次和 6-7 次 PRN 注射的患者中，损失范围为 4.0（95%置信区间为 0.7 至 7.3）至 -4.6（95%置信区间为-11.8 至 2.6）个字母）。在 BRAVO 和 CRUISE（先导试验）中，患者在每月给药的 M6 时从基线分别获得了 19.3 和 15.0 个字母的平均改善，并且从 M6 到 M12 的 PRN 维持了这些改善。然而，在 HORIZON 中，从基线到 M12 的平均 BCVA 变化情况各不相同（在 BRAVO 和 CRUISE 的 PRN 前阶段分别接受 0 次和 6 次注射的患者中，范围为-0.4（95%置信区间为-2.5 至 1.6）至-3.6（95%置信区间为-6.2 至-1.0）个字母）。
BRVO/CRVO 患者群体存在异质性，对雷珠单抗治疗的反应也各不相同。
