학술논문
Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial
Document Type
article
Author
Bing Li; Ke Fan; Tonghe Zhang; Zhifeng Wu; Siming Zeng; Mingwei Zhao; Qian Ren; Dongping Zheng; Lifei Wang; Xiaoling Liu; Mei Han; Yanping Song; Jian Ye; Cheng Pei; Jinglin Yi; Xian Wang; Hui Peng; Hong Zhang; Zhanyu Zhou; Xiaoling Liang; Fangliang Yu; Miaoqin Wu; Chaopeng Li; Chunling Lei; Jilong Hao; Luosheng Tang; Huiping Yuan; Shanjun Cai; Qiuming Li; Jingxiang Zhong; Suyan Li; Lin Liu; Min Ke; Jing Wang; Hui Wang; Mengli Zhu; Zenghua Wang; Yang Yan; Feng Wang; Youxin Chen
Source
Ophthalmology and Therapy, Vol 13, Iss 1, Pp 353-366 (2023)
Subject
Language
English
ISSN
2193-8245
2193-6528
2193-6528
Abstract
Abstract Introduction This trial aimed to compare the efficacy and safety between biosimilar QL1207 and the reference aflibercept for the treatment of neovascular age-related macular degeneration (nAMD). Methods This randomized, double-blind, phase 3 trial was conducted at 35 centers in China. Patients aged ≥ 50 years old with untreated subfoveal choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) letter score of 73–34 were eligible. Patients were randomly assigned to receive intravitreous injections of QL1207 or aflibercept 2 mg (0.05 ml) in the study eye every 4 weeks for the first 3 months, followed by 2 mg every 8 weeks until week 48, stratified by baseline BCVA ≥ or