Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Ophthalmol Retina. 2024 Jan;8(1):10-17. doi: 10.1016/j.oret.2023.08.018. Epub 2023 Sep 9.
A subset of patients with neovascular age-related macular degeneration (nAMD) experience treatment burden and suboptimal response with anti-VEGF therapy. The aim of this study was to investigate the effect of switching to a novel, bispecific agent, faricimab, in patients with nAMD currently treated with anti-VEGF.
Retrospective, noncomparative cohort study.
Patients with nAMD previously treated with anti-VEGF and switched to intravitreal faricimab injection (IFI) at the Cleveland Clinic's Cole Eye Institute.
Switching and administration schedule of IFI was at the discretion of the clinician. Visual acuity (VA) and macular OCT parameters, including central subfield thickness (CST), maximum pigment epithelial detachment (PED) height, and presence of subretinal (SRF) or intraretinal fluid (IRF), were assessed at baseline (day of first IFI) and after each IFI.
Central subfield thickness and presence of IRF or SRF after ≥ 3 IFIs.
One hundred twenty-six eyes of 106 patients were included in the analysis with a mean follow-up time of 24.3 ± 5.2 weeks. Before switching to IFI, patients received a mean of either aflibercept (20.0 ± 8.4, mean ± standard deviation), bevacizumab (7 ± 8.9), ranibizumab (1.9 ± 8.5), or brolucizumab (0.3 ± 1.6) injections. The most common agent used before switching to IFI was aflibercept (n = 110, 87%), and the mean treatment interval with any anti-VEGF was 5.6 ± 1.6 weeks before switching. Central subfield thickness was reduced from baseline after the first IFI (266.8 ± 64.7 vs. 249.8 ± 58.6 μm, P = 0.02) and persisted over the 3 IFIs (P = 0.01). Pigment epithelial detachment height was reduced after the third IFI (249.6 ± 179.0 vs. 206.9 ± 130.0 μm, P = 0.01). The mean VA (62.9 vs. 62.7 approximate ETDRS letters, P = 0.42) and interval between injections (6.3 vs. 5.7 weeks, P = 0.16) was similar after the third IFI compared with baseline. Eleven (8.7%) eyes were switched back to their previous anti-VEGF, including 2 (1.6%) eyes from 1 patient with intraocular inflammation requiring cessation of IFI. There were no other adverse events from switching.
Switching to faricimab resulted in a reduction in mean CST (-11.6 μm, P = 0.01) and PED height (-44.2 μm, P = 0.01) after 3 injections, with stable VA and at a similar treatment interval to prior anti-VEGF therapy.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
一部分新生血管性年龄相关性黄斑变性（nAMD）患者在接受抗血管内皮生长因子（VEGF）治疗时会出现治疗负担和治疗效果欠佳的情况。本研究旨在探讨在接受抗 VEGF 治疗的 nAMD 患者中，转换为新型双特异性药物 faricimab 的效果。
回顾性、非对照队列研究。
克利夫兰诊所Cole 眼科研究所接受过抗 VEGF 治疗且转换为玻璃体腔内 faricimab 注射（IFI）的 nAMD 患者。
IFI 的转换和给药方案由临床医生自行决定。在基线（首次 IFI 当天）和每次 IFI 后评估视力（VA）和黄斑 OCT 参数，包括中心凹下厚度（CST）、最大脉络膜上腔脱离（PED）高度以及是否存在视网膜下（SRF）或视网膜内（IRF）液。
≥3 次 IFI 后 CST 和存在 IRF 或 SRF 的情况。
106 例患者的 126 只眼纳入分析，平均随访时间为 24.3±5.2 周。在转换为 IFI 之前，患者接受了平均 20.0±8.4 次 aflibercept、7±8.9 次 bevacizumab、1.9±8.5 次 ranibizumab 或 0.3±1.6 次 brolucizumab 注射。转换为 IFI 之前最常用的药物是 aflibercept（n=110，87%），在转换前任何抗 VEGF 的平均治疗间隔为 5.6±1.6 周。首次 IFI 后 CST 从基线降低（266.8±64.7 比 249.8±58.6μm，P=0.02），并在 3 次 IFI 后持续降低（P=0.01）。第三次 IFI 后 PED 高度降低（249.6±179.0 比 206.9±130.0μm，P=0.01）。与基线相比，第三次 IFI 后平均 VA（62.9 比 62.7 个近似 ETDRS 字母，P=0.42）和注射间隔（6.3 比 5.7 周，P=0.16）相似。11 只（8.7%）眼转换回之前的抗 VEGF，包括 1 例因眼内炎症需要停止 IFI 治疗的患者中的 2 只眼。从转换中没有观察到其他不良事件。
转换为 faricimab 后，在 3 次注射后 CST（-11.6μm，P=0.01）和 PED 高度（-44.2μm，P=0.01）均有降低，VA 稳定且与之前的抗 VEGF 治疗的治疗间隔相似。
