Two-year outcomes of intravitreal brolucizumab for neovascular age-related macular degeneration: treat, extend, and stop-protocol.

IF 2.4 3区医学 Q2 OPHTHALMOLOGY

Graefe’s Archive for Clinical and Experimental Ophthalmology Pub Date : 2024-12-01 Epub Date: 2024-07-12 DOI:10.1007/s00417-024-06577-9

Hana Yoshida, Satoru Inoda, Hidenori Takahashi, Ryota Takahashi, Yuto Hashimoto, Hironori Takahashi, Hidetoshi Kawashima, Yasuo Yanagi

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引用次数: 0

Abstract

Purpose: To investigate the real-world 2-year treatment outcomes of intravitreal brolucizumab (IVBr) for neovascular age-related macular degeneration (nAMD).

Methods: This multicenter, prospective, and interventional study included 53 eyes treated with brolucizumab from October 2020 to August 2021 at 3 institutions. A modified treat-and-extend (TAE) regimen with predefined discontinuation criteria was used. The mTAE regimen was discontinued if patients responded positively and achieved a treatment interval of 16 weeks twice with no sign of recurrence. The number of patients discontinuing TAE and the visual and anatomic changes at 1 and 2 years after the first IVBr were evaluated.

Results: Thirty-eight eyes from 38 patients (71%) completed the 2-year observation period and 7 eyes from 7 patients experienced intraocular inflammation (IOI). Of these 38 patients, 18 (47%) could discontinue the TAE at a median [interquartile range] of 13.1 [12.9-16.8] months after the first IVBr. Best-corrected visual acuity, central subfield retinal thickness, and central choroidal thickness were significantly improved compared with baseline at both 1 and 2 years after the first IVBr (all P < 0.001). An extension study revealed a 1-year recurrence rate of 5.6% (standard deviation, 5.4%) after TAE discontinuation.

Conclusions: While IOI is a concern with brolucizumab, careful observation allows discontinuing the TAE regimen in patients treated with IVBr. Moreover, brolucizumab may reduce the risk of recurrence after treatment interruption.

Trial registration number: UMIN Clinical Trials Registry ( http://www.umin.ac.jp/ ; R000050688 UMIN 000044374).

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静脉内布卢单抗治疗新生血管性老年黄斑变性的两年疗效：治疗、延长和停止方案。

目的：研究玻璃体内brolucizumab（IVBr）治疗新生血管性年龄相关性黄斑变性（nAMD）2年的实际治疗效果：这项多中心、前瞻性、干预性研究纳入了3家机构在2020年10月至2021年8月期间使用brolucizumab治疗的53只眼睛。研究采用了预先确定停药标准的改良治疗-延长（TAE）方案。如果患者反应积极，两次治疗间隔达到 16 周且无复发迹象，则终止 mTAE 方案。对停用 TAE 的患者人数以及首次 IVBr 治疗后 1 年和 2 年的视觉和解剖变化进行了评估：38名患者中的38只眼睛（71%）完成了为期2年的观察，7名患者中的7只眼睛出现了眼内炎症（IOI）。在这 38 名患者中，有 18 名（47%）在首次 IVBr 后 13.1 [12.9-16.8] 个月的中位数[四分位间范围]可以停止 TAE。在首次 IVBr 后 1 年和 2 年，最佳矫正视力、中央下视网膜厚度和中央脉络膜厚度与基线相比均有显著改善（均为 P 结论：虽然 IOI 是眼科手术中的一个令人担忧的问题，但这并不意味着眼科手术不存在 IOI：虽然IOI是使用brolucizumab的一个顾虑，但仔细观察可以让接受IVBr治疗的患者停止TAE治疗方案。此外，brolucizumab可以降低治疗中断后的复发风险：UMIN 临床试验注册中心 ( http://www.umin.ac.jp/ ; R000050688 UMIN 000044374)。

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来源期刊

Graefe’s Archive for Clinical and Experimental Ophthalmology 医学-眼科学

CiteScore

5.40

自引率

7.40%

发文量

398

审稿时长

3 months

期刊介绍： Graefe''s Archive for Clinical and Experimental Ophthalmology is a distinguished international journal that presents original clinical reports and clini-cally relevant experimental studies. Founded in 1854 by Albrecht von Graefe to serve as a source of useful clinical information and a stimulus for discussion, the journal has published articles by leading ophthalmologists and vision research scientists for more than a century. With peer review by an international Editorial Board and prompt English-language publication, Graefe''s Archive provides rapid dissemination of clinical and clinically related experimental information.