Scampoli Alessandra, Carlà Matteo Mario, Grieco Giulia, Governatori Lorenzo, Catalani Roberta, Rizzo Stanislao, Caporossi Tomaso
Vitreoretinal Surgery Unit, Isola Tiberina Hospital - Gemelli Isola, Rome, Italy.
Ophthalmology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS", 00168, Rome, Italy.
Int Ophthalmol. 2025 Aug 19;45(1):342. doi: 10.1007/s10792-025-03717-w.
To investigate the 12-month effectiveness and safety of intravitreal faricimab (IVF) in patients with neovascular age-related macular degeneration (nAMD) resistant to previous anti-VEGF treatment.
Prospective, monocentric study including consecutive patients with resistant/refractory nAMD switched to IVF between July 2023 and November 2024. Primary endpoints were safety, best corrected visual acuity (BCVA), central subfield thickness (CST), and subfoveal choroidal thickness. Secondary endpoints included changes in optical coherence tomography (OCT) and OCT angiography biomarkers: fluid prevalence, pigment epithelial detachment (PED) height, and vascular densities. All patients received four monthly loading doses of faricimab, with subsequent treat-and-extend regimen.
The study included 30 eyes of 30 patients. Mean follow-up was 14.2 ± 1.9 months and no adverse events were reported. BCVA significantly improved from 0.77 to 0.62 LogMAR at the end of the study period (p = 0.009), with 67% of eyes showing stable vision. CST significantly decreased from baseline (-57 μm on average, p < 0.001), along with PED height which showed its main decrease during the loading phase. Forty-seven percent of eyes achieved complete macular dryness at week 16, with significant reduction in terms of subretinal fluid (SRF) and intraretinal fluid (IRF) prevalence. At the end of the study, 90% of patients achieved treatment intervals of at least q8w, with 27% of eyes being on q12w. Finally, no changes in superficial/deep vessel densities were observed.
Faricimab demonstrated efficacy and safety in refractory/resistant nAMD, with significant improvements in structural outcomes and stable/improved visual acuity. Extended treatment intervals suggest a potential reduction in treatment burden.
研究玻璃体内注射法西单抗(IVF)对先前抗血管内皮生长因子(VEGF)治疗耐药的新生血管性年龄相关性黄斑变性(nAMD)患者的12个月疗效和安全性。
前瞻性单中心研究,纳入2023年7月至2024年11月间连续转为接受IVF治疗的耐药/难治性nAMD患者。主要终点为安全性、最佳矫正视力(BCVA)、中心子场厚度(CST)和黄斑下脉络膜厚度。次要终点包括光学相干断层扫描(OCT)和OCT血管造影生物标志物的变化:液体发生率、色素上皮脱离(PED)高度和血管密度。所有患者每月接受4次法西单抗负荷剂量注射,随后采用治疗并延长方案。
该研究纳入了30例患者的30只眼。平均随访时间为14.2±1.9个月,未报告不良事件。研究期末,BCVA从0.77 LogMAR显著提高至0.62 LogMAR(p = 0.009),67%的眼睛视力稳定。CST较基线水平显著降低(平均降低57μm,p < 0.001),PED高度在负荷期主要降低。47%的眼睛在第16周实现了黄斑完全干燥,视网膜下液(SRF)和视网膜内液(IRF)发生率显著降低。研究结束时,90%的患者治疗间隔至少为每8周一次,27%的眼睛为每12周一次。最后,未观察到浅表/深部血管密度的变化。
法西单抗在难治性/耐药性nAMD中显示出疗效和安全性,结构结局显著改善,视力稳定/提高。延长治疗间隔表明治疗负担可能减轻。