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.
Graefes Arch Clin Exp Ophthalmol. 2025 May 6. doi: 10.1007/s00417-025-06849-y.
To explore the 1-year functional and anatomic outcomes of treatment-naïve neovascular age-related macular degeneration (nAMD) eyes undergoing a treat and extend (TAE) regimen with faricimab, METHODS: Prospective interventional study on 33 eyes with treatment-naïve nAMD undergoing a loading phase of 4 monthly faricimab followed by a TAE regimen. Participants underwent functional assessment and retinal imaging with optical coherence tomography and angiography (OCT/OCTA), at baseline and follow-up visits (V0-V5). Primary outcomes were safety, changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST). Secondary outcomes included changes in OCT biomarkers (intraretinal and subretinal fluid [IRF and SRF], maximum pigment epithelium detachment [PED] height) and vascular densities (VD) in the superficial (SCP) and deep capillary plexuses (DCP).
Mean follow-up was 14.1 ± 2.7 months. At the final visit, 36.4% eyes were on a q16w regimen, and 36.4% on q12w. Results showed significant reductions in CST (V0: 334 ± 102 μm, V5: 227 ± 47 μm, p < 0.001), presence of IRF/SRF and PED height. BCVA improved significantly from 0.51 ± 0.23 to 0.36 ± 0.26 LogMAR (p = 0.03). A dry macula after the loading phase was achieved in 63.7% of cases and correlated with longer inter-injections intervals during TAE. SCP's VD showed a transient decrease in V1-V3 but returned to baseline values at V5, while no significant changes were observed in DCP VD. No cases of intraocular inflammation or adverse events were observed.
Faricimab showed favorable results in treatment-naive nAMD, leading to structural and functional improvements and allowing for extended treatment intervals even in real-world setting.
探讨初治的新生血管性年龄相关性黄斑变性（nAMD）眼采用阿柏西普治疗并延长（TAE）方案的1年功能和解剖学结果。方法：对33只初治nAMD眼进行前瞻性干预研究，先进行4个月每月1次的阿柏西普负荷期治疗，随后采用TAE方案。参与者在基线和随访就诊（V0-V5）时接受功能评估以及光学相干断层扫描和血管造影（OCT/OCTA）视网膜成像。主要结局为安全性、最佳矫正视力（BCVA）和中心子野厚度（CST）的变化。次要结局包括OCT生物标志物（视网膜内和视网膜下液[IRF和SRF]、最大色素上皮脱离[PED]高度）的变化以及浅层（SCP）和深层毛细血管丛（DCP）血管密度（VD）的变化。结果：平均随访时间为14.1±2.7个月。在最后一次就诊时，36.4%的眼采用每16周1次的方案，36.4%采用每12周1次的方案。结果显示CST显著降低（V0：334±102μm，V5：227±47μm，p<0.001），IRF/SRF和PED高度降低。BCVA从0.51±0.23显著改善至0.36±0.26 LogMAR（p=0.03）。63.7%的病例在负荷期后实现黄斑干燥，且与TAE期间更长的注射间隔相关。SCP的VD在V1-V3出现短暂下降，但在V5恢复至基线值，而DCP的VD未观察到显著变化。未观察到眼内炎症或不良事件病例。结论：阿柏西普在初治nAMD中显示出良好结果，导致结构和功能改善，即使在现实世界环境中也能延长治疗间隔。
