Department of Ophthalmology, Rigshospitalet, Valdemar Hansens Vej 1-23, 2600, Glostrup, Denmark.
Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
Graefes Arch Clin Exp Ophthalmol. 2024 Jul;262(7):2153-2162. doi: 10.1007/s00417-024-06421-0. Epub 2024 Feb 28.
To report short-term outcomes of treatment switch to faricimab in real-world patients with aflibercept-resistant neovascular age-related macular degeneration (AMD).
Single-center, retrospective cohort study with chart-review using electronic injection database, electronic medical records, and optical coherence tomography (OCT) data from May to September 2023.
A total of 50 eyes of 46 patients were analyzed. Faricimab treatment led to absence of fluid in 32% of the eyes and a reduction of fluid in 84% of the eyes. There was a statistically significant decrease in central retinal thickness (CRT) and pigment epithelial detachment (PED) height in those that responded to the switch (median difference: - 31 μm, IQR: 55, p < 0.0001 and median difference: - 21 μm, IQR: 36, p < 0.0001, respectively) and a statistically significant increase in CRT (median difference: + 19 μm, IQR: 20, p = 0.0143) and no change in PED height (median difference: + 22 μm, IQR: 64, p = 0.1508) in those that did not. Best-corrected visual acuity (BCVA) showed marginal decrease with low statistical significance. No ocular or systemic safety events were observed.
Our findings suggest that switching to faricimab is generally safe and effective in patients with neovascular AMD who are otherwise difficult to treat and have residual fluid despite frequent injections with aflibercept. We observed a high rate of morphological response to the treatment switch, improvement of anatomical parameters with about one-third of patients having dry macula following a single injection, and a marginal change in BCVA. Sustainability of these results requires further investigation.
ClinicalTrials.gov registration number: NCT06124677. Date of registration: 09/11/2023, retrospectively registered.
报告在阿柏西普耐药新生血管性年龄相关性黄斑变性（AMD）的真实世界患者中，转换为 faricimab 的短期治疗结果。
这是一项 5 月至 9 月 2023 年进行的、使用电子注射数据库、电子病历和光学相干断层扫描（OCT）数据进行回顾性单中心队列研究。
共分析了 46 名患者的 50 只眼。faricimab 治疗使 32%的眼睛无积液，84%的眼睛积液减少。对转换有反应的患者的中央视网膜厚度（CRT）和色素上皮脱离（PED）高度均有统计学显著下降（中位数差异：-31μm，IQR：55，p<0.0001 和中位数差异：-21μm，IQR：36，p<0.0001，分别），而无反应的患者 CRT 统计学显著增加（中位数差异：+19μm，IQR：20，p=0.0143），PED 高度无变化（中位数差异：+22μm，IQR：64，p=0.1508）。最佳矫正视力（BCVA）略有下降，但统计学意义较低。未观察到眼部或全身安全事件。
我们的发现表明，对于那些即使频繁注射阿柏西普仍难以治疗且有残留积液的新生血管性 AMD 患者，转换为 faricimab 通常是安全有效的。我们观察到治疗转换的形态学反应率较高，大约三分之一的患者单次注射后黄斑干燥，解剖学参数得到改善，BCVA 略有变化。这些结果的可持续性需要进一步研究。
ClinicalTrials.gov 注册号：NCT06124677。注册日期：2023 年 9 月 11 日，回溯性注册。
