法西单抗治疗1型黄斑新生血管的疗效：初治眼和转换眼12个月内色素上皮脱离（PED）体积减少的人工智能辅助定量分析

Faricimab efficacy in type 1 macular neovascularization: AI-assisted quantification of pigment epithelium detachment (PED) volume reduction over 12 months in Naïve and switch eyes.

作者信息

Cattaneo Jennifer, Forte Paolo, Forte Giovanni, Eandi Chiara M

机构信息

Fondation Asile des Aveugles, Department of Ophthalmology, Jules-Gonin Eye Hospital, University of Lausanne, Avenue de France 54, Lausanne, 1001, Switzerland.

Eye Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

出版信息

Int J Retina Vitreous. 2025 Jan 9;11(1):3. doi: 10.1186/s40942-025-00629-w.

DOI:10.1186/s40942-025-00629-w

PMID:39789631

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11720305/

Abstract

BACKGROUND

This study evaluates the efficacy of intravitreal Faricimab in reducing pigment epithelium detachment (PED) and fluid volumes in both treatment-naïve eyes and eyes unresponsive to anti-VEGF mono-therapies, all diagnosed with type 1 macular neovascularization (T1 MNV) over a period of 12-month.

METHODS

A retrospective, single-center cohort study was conducted at the Jules Gonin Eye Hospital, Lausanne, Switzerland. Clinical records of treatment-naïve and non-responder switch patients presenting T1 MNV secondary to neovascular age-related macular degeneration (nAMD) from September 2022 to March 2023 were reviewed. Patients received a loading dose of three monthly Faricimab injections followed by a treat-and-extend (T&E) regimen. Multimodal imaging, including structural OCT and AI-assisted analysis, was used to quantify PED volumes and related fluid biomarkers at baseline, 3-month, 6-month, and 12-month follow-up. Statistical analyses included linear mixed models to evaluate differences and trends in intraretinal (IRF), subretinal fluid (SRF) and PED volumes.

RESULTS

65 eyes of 65 patients were enrolled (female: 70.7%; mean age = 80.7yrs, SD = 6.9yrs). 80% had received anti-VEGF treatment (Switch group) and 20% were treatment-Naïve at baseline. At 12 months, intravitreal treatments were more frequent in the Switch group (mean number = 8.3 vs. 6.0; p = 0.009). BCVA improved at the 12-month follow-up in Naïve eyes (+ 6.9 ETDRS letters from baseline, p = 0.053) and was maintained in Switch eyes. No cases of intraocular inflammation were observed. Significant reduction in SRF and IRF volumes were noted in both groups. A significant reduction in PED volume was observed over the follow-up period in both groups (mean slope = -206 nL, 95%CL = -273/-138; p-value < 0.001).

CONCLUSIONS

Intravitreal Faricimab significantly reduced PED volumes in both treatment-Naïve and non-responder Switch patients over 12 months. The study highlights Faricimab's potential as an effective treatment option for T1 MNV in nAMD, offering significant improvements in PED volume and related fluid biomarkers.

摘要

背景

本研究评估玻璃体内注射法西单抗在减少初治眼和对抗血管内皮生长因子（anti-VEGF）单药治疗无反应的眼中色素上皮脱离（PED）和液体体积的疗效，所有患者均被诊断为1型黄斑新生血管（T1 MNV），随访期为12个月。

方法

在瑞士洛桑的朱尔斯·戈宁眼科医院进行了一项回顾性单中心队列研究。回顾了2022年9月至2023年3月期间因新生血管性年龄相关性黄斑变性（nAMD）继发T1 MNV的初治患者和无反应转换患者的临床记录。患者接受每月3次的法西单抗负荷剂量注射，随后采用治疗并延长（T&E）方案。在基线、3个月、6个月和12个月随访时，使用包括结构光学相干断层扫描（OCT）和人工智能辅助分析在内的多模态成像来量化PED体积和相关的液体生物标志物。统计分析包括线性混合模型，以评估视网膜内（IRF）、视网膜下液（SRF）和PED体积的差异和趋势。

结果

纳入了65例患者的65只眼（女性：70.7%；平均年龄 = 80.7岁，标准差 = 6.9岁）。80%的患者在基线时接受过抗VEGF治疗（转换组），20%为初治患者。在12个月时，转换组的玻璃体内治疗更频繁（平均次数 = 8.3次对6.0次；p = 0.009）。初治眼在12个月随访时最佳矫正视力（BCVA）有所改善（较基线提高6.9个ETDRS字母，p = 0.053），转换组的视力得以维持。未观察到眼内炎症病例。两组的SRF和IRF体积均显著减少。在随访期间，两组的PED体积均显著减少（平均斜率 = -206 nL，95%置信区间 = -273/-138；p值 < 0.001）。