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玻璃体内注射布罗珠单抗治疗难治性新生血管性年龄相关性黄斑变性的第一年真实世界经验。

First-year real-world experience of intravitreal brolucizumab injection for refractory neovascular age-related macular degeneration.

作者信息

Lee Jeong Hyun, Shin Joo Young, Ahn Jeeyun

机构信息

Department of Ophthalmology, Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.

出版信息

Jpn J Ophthalmol. 2025 Jan;69(1):43-48. doi: 10.1007/s10384-024-01134-7. Epub 2024 Nov 5.

Abstract

PURPOSE

To investigate the first-year real-world anatomical and functional outcomes of intravitreal brolucizumab injection in eyes with refractory neovascular age-related macular degeneration (nAMD).

STUDY DESIGN

Retrospective observational study.

METHODS

nAMD patients who showed poor response to previous anti-vascular endothelial growth factor (VEGF) agents were switched to brolucizumab. Functional and anatomical outcomes were evaluated at initial treatment of nAMD, after treatment with other anti-VEGF agents and after switching and treating with brolucizumab for 1 year. Safety profile was also evaluated after brolucizumab injection. Best-corrected visual acuity (BCVA), central foveal thickness (CFT), subfoveal choroidal thickness (SFCT), and the presence of fluid in different compartments (intraretinal fluid [IRF], subretinal fluid [SRF], pigment epithelial detachment [PED]) were assessed at each time point.

RESULTS

A total of 40 eyes of 40 patients were included in the study. BCVA remained unchanged throughout treatment (p > 0.05). CFT did not change after treatment with other anti-VEGF agents (p = 0.588) but decreased after switching to brolucizumab (p < 0.001). SFCT decreased after treatment with other anti-VEGF agents (p = 0.025) but not after switching to brolucizumab (p = 0.236). Presence of SRF (p = 0.001) and PED (p = 0.001) decreased significantly after switching to brolucizumab, despite their persistence with prior treatments using other anti-VEGF agents. However, IRF persisted even after switching to brolucizumab (p = 0.745). Intraocular inflammation (IOI)-related adverse events were reported in 3 eyes (7.14%).

CONCLUSION

Analysis of first-year real-world outcomes after switching to brolucizumab in nAMD patients refractory to other anti-VEGF agents showed improved anatomic outcomes, limited functional improvement and low incidence of IOI-related adverse events.

摘要

目的

研究玻璃体内注射布罗珠单抗治疗难治性新生血管性年龄相关性黄斑变性(nAMD)患者的第一年真实世界解剖学和功能结局。

研究设计

回顾性观察研究。

方法

对先前抗血管内皮生长因子(VEGF)药物反应不佳的nAMD患者改用布罗珠单抗。在nAMD初始治疗时、使用其他抗VEGF药物治疗后以及改用布罗珠单抗治疗1年后评估功能和解剖学结局。在注射布罗珠单抗后还评估了安全性。在每个时间点评估最佳矫正视力(BCVA)、中心凹厚度(CFT)、黄斑下脉络膜厚度(SFCT)以及不同腔隙(视网膜内液[IRF]、视网膜下液[SRF]、色素上皮脱离[PED])中液体的存在情况。

结果

本研究共纳入40例患者的40只眼。整个治疗过程中BCVA保持不变(p>0.05)。使用其他抗VEGF药物治疗后CFT未改变(p = 0.588),但改用布罗珠单抗后CFT降低(p<0.001)。使用其他抗VEGF药物治疗后SFCT降低(p = 0.025),但改用布罗珠单抗后未降低(p = 0.236)。改用布罗珠单抗后,SRF(p = 0.001)和PED(p = 0.001)的存在显著减少,尽管在先前使用其他抗VEGF药物治疗时它们持续存在。然而,即使改用布罗珠单抗后IRF仍持续存在(p = 0.745)。3只眼(7.14%)报告了与眼内炎症(IOI)相关的不良事件。

结论

对难治性nAMD患者改用布罗珠单抗后的第一年真实世界结局分析显示,解剖学结局改善、功能改善有限且与IOI相关的不良事件发生率低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99d0/11821690/2b5307b94e8f/10384_2024_1134_Fig1_HTML.jpg

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