1. Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial
- Author
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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, and Youxin Chen
- Subjects
Neovascular age-related macular degeneration ,QL1207 ,Aflibercept ,Biosimilar ,Ophthalmology ,RE1-994 - 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
- Published
- 2023
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