法瑞昔单抗玻璃体内治疗视网膜静脉阻塞继发黄斑水肿的实际疗效:短期结果和光学相干断层扫描生物标志物分析。

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2025-10-04 eCollection Date: 2025-01-01 DOI:10.2147/OPTH.S549896
Soichiro Inokuchi, Yuki Mizuki, Akihiro Kamata, Junji Onishi, Takahiko Hayashi, Nobuhisa Mizuki
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引用次数: 0

摘要

背景:视网膜静脉阻塞(RVO)是第二常见的视网膜血管疾病,也是黄斑水肿(ME)引起视力损害的主要原因。Faricimab是一种新型的双特异性抗体,靶向VEGF-A和血管生成素-2,在临床试验中显示出希望;然而,关于其对RVO继发ME (RVO-ME)的有效性和安全性的实际数据仍然有限。目的:在日本现实世界的临床环境中评估玻璃体内法利昔单抗治疗RVO-ME的短期疗效和安全性,并探讨基线光学相干断层扫描(OCT)生物标志物与治疗结果之间的关系。方法:本回顾性观察性研究在日本横滨国际亲善医院进行,纳入23只眼RVO-ME,玻璃体内法利昔单抗治疗。评估3个月内最佳矫正视力(BCVA, logMAR)和中心子野厚度(CST)的变化。分析基线OCT生物标志物与视觉和解剖反应的关系。亚组分析比较treatment-naïve和以前治疗过的眼睛。结果:注射次数中位数为1次,52.2%的眼实现了黄斑液的完全溶解。中位BCVA从0.40 logMAR显著改善到0.22 logMAR (p = 0.0025),中位CST从352µm下降到194µm (p < 0.001)。treatment-naïve眼(p = 0.048)和慢性囊肿眼(p = 0.015) CST降低较大。没有OCT生物标志物与BCVA改善显著相关。未观察到眼部或全身不良事件。结论:在这项现实世界的研究中,玻璃体内法利西单抗对RVO-ME有效且耐受性良好。即使是一次注射也经常导致解剖和功能的改善。这些结果支持法利西单抗的临床应用,并提示OCT生物标志物在预测治疗反应方面的潜在作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Efficacy of Intravitreal Faricimab for Macular Edema Secondary to Retinal Vein Occlusion: Short-Term Outcomes and Optical Coherence Tomography Biomarker Analysis.

Background: Retinal vein occlusion (RVO) is the second most common retinal vascular disease and a major cause of visual impairment due to macular edema (ME). Faricimab, a novel bispecific antibody targeting both VEGF-A and angiopoietin-2, has shown promise in clinical trials; however, real-world data on its efficacy and safety for ME secondary to RVO (RVO-ME) remain limited.

Objective: To evaluate the short-term efficacy and safety of intravitreal faricimab for RVO-ME in a real-world Japanese clinical setting, and to explore associations between baseline optical coherence tomography (OCT) biomarkers and treatment outcomes.

Methods: This retrospective observational study was conducted at the International Goodwill Hospital, Yokohama, Japan, and included 23 eyes with RVO-ME treated with intravitreal faricimab. Changes in best-corrected visual acuity (BCVA, logMAR) and central subfield thickness (CST) over 3 months were assessed. Baseline OCT biomarkers were analyzed for associations with visual and anatomical responses. Subgroup analyses compared treatment-naïve and previously treated eyes.

Results: The median number of injections was 1, and 52.2% of eyes achieved complete resolution of macular fluid. Median BCVA improved significantly from 0.40 to 0.22 logMAR (p = 0.0025), and median CST decreased from 352 µm to 194 µm (p < 0.001). Greater CST reduction was observed in treatment-naïve eyes (p = 0.048) and in eyes with chronic cyst (p = 0.015). No OCT biomarker was significantly associated with BCVA improvement. No ocular or systemic adverse events were observed.

Conclusion: Intravitreal faricimab was effective and well-tolerated for RVO-ME in this real-world study. Even a single injection frequently led to anatomical and functional improvement. These results support the clinical utility of faricimab and suggest a potential role for OCT biomarkers in predicting treatment response.

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