Lai Yen-An, Tsui Mei-Chi, Cheng Shuo-Fang, Hsieh Yi-Ting, Lai Tso-Ting, Hsia Yun, Wang Shih-Wen, Ma I-Hsin, Hung Kuo-Chi, Lin Chang-Pin, Yang Chang-Hao, Yang Chung-May, Ho Tzyy-Chang
School of Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
Department of Ophthalmology, National Taiwan University Hospital, No. 7, Chun-Shan S. Rd., Taipei City, 100, Taiwan.
Ophthalmol Ther. 2025 Jun 4. doi: 10.1007/s40123-025-01163-6.
Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss, with some eyes showing recalcitrant disease despite standard anti-vascular endothelial growth factor (anti-VEGF) therapy. While clinical trials have demonstrated promising efficacy and safety of faricimab in treatment-naïve patients, only 9% of participants were Asian, and real-world data on its effectiveness in pretreated Asian populations remain limited. This study aims to evaluate the efficacy and longitudinal response of intravitreal faricimab in patients with recalcitrant nAMD in Taiwan by analyzing visual acuity, anatomical outcomes, and treatment interval extension over a 6-month period.
This was a retrospective observational study at National Taiwan University Hospital. Patients switched to intravitreal faricimab (6 mg/0.05 mL; Vabysmo™) from July 2023 to May 2024 with 6 months follow-up identified via electronic medical records. Injections were administered without a loading phase. Retreatment was guided by the presence of retinal fluid on optical coherence tomography (OCT), with or without visual decline.
A total of 33 eyes from 28 patients were analyzed. Visual acuity remained stable over 6 months (p = 0.147). Central retinal thickness significantly improved from 267 to 235 μm at 3 months (p = 0.002) and remained stable at 6 months (p = 0.003). Subretinal fluid resolved in 36.4% of eyes at 3 months (p < 0.001) and 48.5% at 6 months (p = 0.002), while changes in intraretinal fluid (IRF) and pigment epithelial detachment (PED) height were not significant. Treatment intervals were extended in 52% of eyes, with 56% reaching ≥ 16 weeks (Q16W) intervals. No serious ocular or systemic adverse events were reported.
Intravitreal faricimab demonstrated improved anatomical outcomes with stable visual acuity and extended treatment intervals in patients with recalcitrant nAMD in Taiwan, addressing a key evidence gap. Future studies with longer follow-ups are needed to validate these findings.
新生血管性年龄相关性黄斑变性（nAMD）是导致视力丧失的主要原因，尽管采用标准抗血管内皮生长因子（抗VEGF）治疗，仍有部分患者病情顽固。虽然临床试验已证明法西单抗在初治患者中具有良好的疗效和安全性，但只有9%的参与者为亚洲人，关于其在经治亚洲人群中的有效性的真实世界数据仍然有限。本研究旨在通过分析台湾地区顽固性nAMD患者6个月期间的视力、解剖学结果和治疗间隔延长情况，评估玻璃体内注射法西单抗的疗效和纵向反应。
这是一项在台湾大学附属医院进行的回顾性观察研究。通过电子病历识别出2023年7月至2024年5月期间改用玻璃体内注射法西单抗（6mg/0.05mL；Vabysmo™）并进行6个月随访的患者。注射时不设负荷期。根据光学相干断层扫描（OCT）上视网膜积液的情况，无论有无视力下降，指导再次治疗。
共分析了28例患者的33只眼。6个月内视力保持稳定（p=0.147）。3个月时，中心视网膜厚度从267μm显著改善至235μm（p=0.002），6个月时保持稳定（p=0.003）。3个月时，36.4%的患眼视网膜下液消退（p<0.001），6个月时为48.5%（p=0.002），而视网膜内液（IRF）和色素上皮脱离（PED）高度的变化不显著。52%的患眼治疗间隔延长，56%的患眼达到≥16周（Q16W）的间隔。未报告严重的眼部或全身不良事件。
在台湾地区顽固性nAMD患者中，玻璃体内注射法西单抗显示出改善的解剖学结果、稳定的视力和延长的治疗间隔，填补了关键的证据空白。需要进行更长时间随访的未来研究来验证这些发现。
