Bilgic Alper, Kodjikian Laurent, March de Ribot Francesc, Vasavada Vaishali, Gonzalez-Cortes Jesus H, Abukashabah Amro, Sudhalkar Aditya, Mathis Thibaud
Alphavision Augenarztpraxis, 27568 Bremerhaven, Germany.
Service d'Ophtalmologie, Centre Hospitalier Universitaire de la Croix-Rousse, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, 69004 Lyon, France.
J Clin Med. 2021 Jun 23;10(13):2758. doi: 10.3390/jcm10132758.
The aim of the present study was to determine the efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) in the real-world setting. The REBA study (real-world experience with brolucizumab in wet AMD) was a retrospective, observational, multicentric study that included 78 consecutive patients (105 eyes), with neovascular AMD, who received brolucizumab therapy. Both treatment-naive and switch-therapy patients were included. Switch therapy was based either on fluid recurrence, fluid recalcitrance, or inability to extend beyond q4/q6. All relevant data were collected. The primary outcome measure was change in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included determination of change in central subfield thickness (CST) and complications. The mean baseline BCVA was 49.4 ± 5.4 letters and 40 ± 3.2 letters, and corresponding mean BCVA gain was +11.9 ± 3.9 letters ( = 0.011) and +10.4 ± 4.8 letters ( = 0.014) in the treatment-naive and switch-therapy groups, respectively. The change in CST was significantly decreased in the treatment-naive ( = 0.021) and the switch-therapy ( = 0.013) groups. The mean follow-up was 10.4 months in both groups. One patient in the switch-therapy group developed vascular occlusion and another a macular hole after the fifth brolucizumab injection. Both patients recovered uneventfully. In conclusion, patients showed a very good anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Two significant untoward events were noted.
本研究的目的是确定在现实环境中玻璃体内注射布罗卢izumab治疗新生血管性年龄相关性黄斑变性(AMD)的疗效和安全性。REBA研究(布罗卢izumab治疗湿性AMD的真实世界经验)是一项回顾性、观察性、多中心研究,纳入了78例连续接受布罗卢izumab治疗的新生血管性AMD患者(105只眼)。初治患者和转换治疗患者均被纳入。转换治疗基于液体复发、液体顽固性或无法延长至每4/6周一次。收集了所有相关数据。主要结局指标是最佳矫正视力(BCVA)随时间的变化。次要结局指标包括中心子场厚度(CST)的变化测定和并发症。初治组和转换治疗组的平均基线BCVA分别为49.4±5.4字母和40±3.2字母,相应的平均BCVA改善分别为+11.9±3.9字母(P = 0.011)和+10.4±4.8字母(P = 0.014)。初治组(P = 0.021)和转换治疗组(P = 0.013)的CST变化均显著降低。两组的平均随访时间均为10.4个月。转换治疗组有1例患者在第5次注射布罗卢izumab后发生血管阻塞,另1例发生黄斑裂孔。两名患者均顺利康复。总之,在随访期结束前,无论先前的治疗状态如何,患者在现实世界中对布罗卢izumab治疗均表现出非常好的解剖和功能反应。记录到两起严重不良事件。