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Brolucizumab 治疗湿性年龄相关性黄斑变性:来自一家三级中心的一年真实世界经验。

Brolucizumab for Wet Age-Related Macular Degeneration: One-Year Real-World Experience from a Tertiary Center.

机构信息

Ocular Oncology Unit, "Fondazione Policlinico Universitario A. Gemelli, IRCCS", Rome, Italy.

Catholic University "Sacro Cuore", Rome, Italy.

出版信息

Ophthalmologica. 2023;246(1):58-67. doi: 10.1159/000529817. Epub 2023 Feb 24.

Abstract

INTRODUCTION

The aim of this study was to explore the early efficacy and safety of treatment with intravitreal injections (IVIs) of brolucizumab in patients presenting with neovascular age-related macular degeneration (nAMD) in a real-world setting.

METHODS

This retrospective study included 194 eyes of 180 patients with nAMD treated with standard 6-mg IVIs of brolucizumab in our clinic between March 11, 2021, and June 15, 2022. Both treatment-naive (33 eyes) and switch therapy patients (161 eyes) were included in the study. Best corrected visual acuity (BCVA), central subfield thickness (CST), retinal fluid distribution (classified as intraretinal, subretinal, under the pigmented epithelium), treatment intervals, and adverse event rates were collected for analysis.

RESULTS

Average follow-up time was 37.2 ± 16.6 weeks. Mean baseline BCVAs were 38.1 ± 4.5 and 41.9 ± 6.7 letters in the treatment-naive and switch therapy groups, with a final gain of 16.0 ± 4.9 (p < 0.0001) and 10.7 ± 5.9 (p < 0.0001) letters in the two groups, respectively. Throughout the study period, CST significantly decreased in both treatment naïve (from 352.0 ± 129.4 to 284.2 ± 93.8 µm; p = 0.0015) and switch therapy (from 369.9 ± 140.5 to 307.4 ± 123.5 µm; p < 0.0001). Significant fluid control rates were achieved at the end of the study period (45% and 27% eyes were completely free of fluid in naïve and switch groups, respectively). Five eyes (2.6%) developed adverse events with different grades of intraocular inflammation and visual outcomes.

CONCLUSION

Brolucizumab IVI showed very good anatomical and functional outcomes in both naive and switch patients in this real-world experience. Nevertheless, even showing a favorable risk/benefit profile, clinicians and patients should be aware of the possibility of a small rate of severe complications.

摘要

简介

本研究旨在探讨在真实环境中,使用玻璃体腔内注射布罗利珠单抗(brolucizumab)治疗新生血管性年龄相关性黄斑变性(nAMD)患者的早期疗效和安全性。

方法

本回顾性研究纳入了 2021 年 3 月 11 日至 2022 年 6 月 15 日期间在我院接受标准 6mg 玻璃体腔内注射布罗利珠单抗治疗的 180 例患者的 194 只眼。研究纳入了初治(33 只眼)和转换治疗(161 只眼)患者。收集最佳矫正视力(BCVA)、中心视网膜下厚度(CST)、视网膜内液(视网膜内、视网膜下、色素上皮下)分布、治疗间隔和不良反应发生率等数据进行分析。

结果

平均随访时间为 37.2±16.6 周。初治组和转换治疗组的基线 BCVA 分别为 38.1±4.5 和 41.9±6.7 个字母,最终分别增加了 16.0±4.9(p<0.0001)和 10.7±5.9(p<0.0001)个字母。在整个研究期间,两组患者的 CST 均显著降低(初治组从 352.0±129.4 降至 284.2±93.8 µm;p=0.0015;转换治疗组从 369.9±140.5 降至 307.4±123.5 µm;p<0.0001)。在研究结束时,两组患者的液体控制率均显著提高(初治组和转换治疗组分别有 45%和 27%的眼完全无液)。5 只眼(2.6%)出现不同程度的眼内炎症和视力不良等不良反应。

结论

在本真实世界研究中,brolucizumab IVI 治疗初治和转换治疗患者均取得了非常好的解剖和功能结局。尽管显示出有利的风险/获益比,但临床医生和患者仍应意识到发生严重并发症的可能性较小。

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