Cancian Giuseppe, Paris Arianna, Agliati Lia, Rizzato Angelica, Clerici Michele, Volpe Giulio, Menghini Moreno, Grimaldi Gabriela
Department of Ophthalmology, Institute of Clinical Neurosciences of Southern Switzerland (INSI), Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland.
Ophthalmology Department, Ospedale Italiano, Via Pietro Capelli 1, 6962, Viganello, Switzerland.
Ophthalmol Ther. 2024 Nov;13(11):2985-2997. doi: 10.1007/s40123-024-01036-4. Epub 2024 Sep 28.
This study assessed the efficacy, durability, and safety of faricimab in patients with neovascular age-related macular degeneration (nAMD), previously treated with aflibercept or ranibizumab with unsatisfactory results.
This was a single-center, prospective cohort study of all consecutive patients with nAMD switched to intravitreally administered faricimab from traditional anti-vascular endothelial growth factor (anti-VEGF) treatments between September 2022 and April 2023 because of unsatisfactory response (maximal fluid-free interval ≤ 8 weeks). Faricimab was administered with a loading dose of four 4-weekly injections, followed by a treat-and-extend regimen. The primary outcome measures were maximum fluid-free interval after the switch and last assigned treatment interval. Secondary outcome measures included best-corrected visual acuity (BCVA) and structural optical coherence tomography parameters.
Thirty-three eyes of 33 patients were included. Patients were followed for a median of 72 weeks [interquartile range 61, 76]. Median maximum fluid-free treatment interval after switch to faricimab and the last assigned interval were significantly longer than before the switch (7 vs. 4 weeks, p < 0.001 and 8 vs. 5 weeks, p < 0.001, respectively). Significant improvements in central subfield thickness (353 vs. 281 µm), macular volume (2.46 vs. 2.16 mm), and pigment epithelial detachment height (198 vs. 150 µm) were observed (all p < 0.001). BCVA remained stable at 0.4 versus 0.3 logMAR before switch (p = 0.190). One eye (3%) developed intraocular inflammation and one eye (3%) developed a retinal pigment epithelium tear.
Faricimab improved anatomical outcomes and allowed longer treatment intervals in patients with nAMD previously treated with other anti-VEGF therapies with unsatisfactory response, reducing treatment burden. A favorable safety profile was observed.
本研究评估了法西单抗在新生血管性年龄相关性黄斑变性（nAMD）患者中的疗效、持久性和安全性，这些患者先前接受阿柏西普或雷珠单抗治疗但效果不佳。
这是一项单中心前瞻性队列研究，研究对象为2022年9月至2023年4月期间所有因反应不佳（最大无液间隔≤8周）从传统抗血管内皮生长因子（抗VEGF）治疗转为玻璃体内注射法西单抗的连续性nAMD患者。法西单抗采用负荷剂量，每4周注射4次，随后采用治疗并延长方案。主要结局指标为转换后的最大无液间隔和最后指定的治疗间隔。次要结局指标包括最佳矫正视力（BCVA）和结构光学相干断层扫描参数。
纳入33例患者的33只眼。患者的中位随访时间为72周[四分位间距61, 76]。转换为法西单抗后的中位最大无液治疗间隔和最后指定的间隔显著长于转换前（分别为7周对4周，p < 0.001；8周对5周，p < 0.001）。观察到中心子场厚度（353对281µm）、黄斑体积（2.46对2.16mm）和色素上皮脱离高度（198对150µm）有显著改善（均p < 0.001）。BCVA在转换前为0.4 logMAR，转换后保持稳定在0.3 logMAR（p = 0.190）。1只眼（3%）发生眼内炎症，1只眼（3%）发生视网膜色素上皮撕裂。
法西单抗改善了解剖学结局，并使先前接受其他抗VEGF治疗但反应不佳的nAMD患者的治疗间隔延长，减轻了治疗负担。观察到良好的安全性。
