Department of Ophthalmology/Paris-Est Créteil University (UPEC, Paris XII University)/Intercommunal Hospital Center and Henri Mondor Hospital, Créteil, France.
Department of Ophthalmology, INSERM-DGOS CIC 1423, Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts, Paris, France.
Ophthalmic Res. 2023;66(1):824-834. doi: 10.1159/000530294. Epub 2023 Mar 27.
Information about real-world ranibizumab use is needed to optimize treatment of macular edema secondary to retinal vein occlusion (RVO). The BOREAL-RVO study assessed treatment use, effectiveness, and safety of 24-month treatment with ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to RVO in a real-world setting.
This was a multicenter, post-authorization, observational study in France, including patients starting ranibizumab for RVO. Primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 6. Secondary endpoints were mean changes from baseline in BCVA at month 24 and central retinal thickness (CRT) at months 6 and 24, and treatment use in real-world setting.
226 branch RVO (BRVO) and 196 central RVO (CRVO) patients were enrolled; 71.7% and 70.9% completed the 24-month follow-up, respectively. In BRVO, mean (SD) baseline BCVA was 55.2 (18.7) letters, with gains of 14.3 (13.7), 14.1 (16.5), 13.0 (17.5), and 11.4 (20.1) letters at months 3, 6, 12, and 24, respectively. In CRVO, mean (SD) baseline BCVA was 40.4 (25.6) letters, with gains of 16.0 (21.2), 9.5 (25.4), 9.2 (27.7), and 8.3 (23.8) letters at months 3, 6, 12, and 24, respectively. At month 24, 52% of BRVO and 41% of CRVO patients had gains of 15 or more letters. In BRVO, mean (SD) CRT values at baseline and months 3, 6, 12, and 24 were 550 (175), 315 (104), 343 (122), 335 (137), and 340 (105) μm. In CRVO, mean (SD) CRT values at baseline and months 3, 6, 12, and 24 were 643 (217), 327 (152), 400 (203), 379 (175), and 348 (161) μm. On average, BRVO patients had 3.8 injections for 6.9 visits by month 6, and 7.2 injections for 19.7 visits by month 24. CRVO patients had 2.7 injections for 4.2 visits by month 6 and 7.1 injections for 21.1 visits by month 24. Factors predictive of better BCVA gain at month 6 were age under 60 at baseline, lower baseline BCVA and BCVA gain at month 3. There were no new safety findings.
Major improvements in BCVA and CRT were observed at month 3 after the induction phase and then were sustained up to month 24, with a slight decrease, probably due to under-treatment. This study demonstrated ranibizumab to be a safe and effective treatment for BRVO and CRVO in the real-world setting, although more regular or proactive treatment could further improve outcomes.
为了优化视网膜静脉阻塞（RVO）继发黄斑水肿的治疗，需要了解真实世界中雷珠单抗的使用情况。BOREAL-RVO 研究评估了 24 个月雷珠单抗 0.5mg 治疗 RVO 继发黄斑水肿导致视力障碍患者的治疗使用情况、疗效和安全性。
这是一项在法国进行的多中心、上市后、观察性研究，纳入了开始接受 RVO 雷珠单抗治疗的患者。主要终点是治疗后 6 个月最佳矫正视力（BCVA）的平均变化。次要终点是治疗后 24 个月 BCVA 的平均变化和中央视网膜厚度（CRT）在第 6 个月和第 24 个月的变化，以及真实世界中的治疗使用情况。
纳入 226 例分支 RVO（BRVO）和 196 例中央 RVO（CRVO）患者；分别有 71.7%和 70.9%完成了 24 个月的随访。在 BRVO 中，基线 BCVA 的平均（SD）为 55.2（18.7）个字母，在第 3、6、12 和 24 个月时分别获得了 14.3（13.7）、14.1（16.5）、13.0（17.5）和 11.4（20.1）个字母的增益。在 CRVO 中，基线 BCVA 的平均（SD）为 40.4（25.6）个字母，在第 3、6、12 和 24 个月时分别获得了 16.0（21.2）、9.5（25.4）、9.2（27.7）和 8.3（23.8）个字母的增益。在第 24 个月时，52%的 BRVO 和 41%的 CRVO 患者的增益达到 15 个或更多字母。在 BRVO 中，基线和第 3、6、12 和 24 个月时 CRT 值的平均（SD）分别为 550（175）、315（104）、343（122）、335（137）和 340（105）μm。在 CRVO 中，基线和第 3、6、12 和 24 个月时 CRT 值的平均（SD）分别为 643（217）、327（152）、400（203）、379（175）和 348（161）μm。平均而言，BRVO 患者在第 6 个月接受了 3.8 次注射和 6.9 次就诊，在第 24 个月接受了 7.2 次注射和 19.7 次就诊。CRVO 患者在第 6 个月接受了 2.7 次注射和 4.2 次就诊，在第 24 个月接受了 7.1 次注射和 21.1 次就诊。第 6 个月 BCVA 增益较好的预测因素是基线时年龄小于 60 岁，以及基线时 BCVA 和第 3 个月时 BCVA 增益较低。没有新的安全性发现。
在诱导期后第 3 个月观察到 BCVA 和 CRT 有显著改善，随后持续到第 24 个月，略有下降，可能是由于治疗不足。这项研究表明，雷珠单抗在真实世界环境中是一种安全有效的 BRVO 和 CRVO 治疗方法，尽管更规律或更积极的治疗可能会进一步改善治疗效果。
