Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration

Summary

A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled. Qualified subjects were divided into experimental group and control group in a 1:1 ratio, and stratified randomized according to the letter value of baseline period and whether the eyes had received anti-VEGF drug treatment. The experimental group received BAT5906 injection. The control group received Lucentis® treatment. Only 1 eye per subject was included in this study.

Conditions

• Neovascular (Wet) Age-related Macular Degeneration

Interventions

DRUG

BAT5906 injection

4.0 mg/eye/time, 50 μl, intravitreal injection

DRUG

Lucentis

0.5 mg/eye/time, 50 μl, intravitreal injection

Sponsors & Collaborators

• Bio-Thera Solutions

  lead INDUSTRY

Principal Investigators

• Youxin Chen, Doctor · Peking Union Medical College

• Xiaolin Liu, Doctor · Affiliated Optometry Hospital of Wenzhou Medical University

• Mingwei Zhao, Doctor · Peking University People's Hospital

• Yi Chen, Doctor · China-Japan Friendship Hospital

• Hong Dai, Doctor · Beijing Hospital

• Yong Tao, Doctor · Beijing Chao Yang Hospital

• Linna Lu, Doctor · The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

• Hongping Cui, Doctor · Shanghai Oriental Hospital

• Xiaolin Liang, Doctor · Sun Yat-sen Ophthalmic Center, Sun Yat-sen University

• Pengxia Wan, Doctor · First Affiliated Hospital, Sun Yat-Sen University

• Yuqing Lan, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Haoyu Chen, Doctor · Shantou University-Chinese University of Hong Kong Joint Shantou International Eye Centre

• Xiyuan Zhou, Doctor · The Second Affiliated Hospital of Chongqing Medical University

• Xiaohong Meng, Doctor · The First Affiliated Hospital of Army Medical University (Southwest Hospital)

• Jinglin Yi, Doctor · The Affiliated Eye Hospital of Nanchang University

• Hongmei Zheng, Doctor · People's Hospital of Wuhan University (Hubei Provincial People's Hospital)

• Liuhua Tong, Doctor · People's Hospital of Quzhou

• Zongming Song, Doctor · Henan Eye Center (Henan Eye Hospital)

• Shenzhi Liang, Doctor · The First Affiliated Hospital of Zhengzhou University

• Junfeng Mao, Doctor · Xiangya Hospital of Central South University

• Xiangwen Shu, Master · Jinan Second People's Hospital

• Yuanbin Li, Doctor · Yantai Yuhuangding Hospital

• Shanjun Cai, Doctor · Zunyi Medical College

• Xian Wang, Doctor · Affiliated Hospital of Guizhou Medical University

• Xu Li, Master · The Fourth People's Hospital of Shenyang

• Rongrong Zhu, Bachelor · Affiliated Hospital of Nantong University

• Wei Wei, Doctor · Jiangsu Provincial Hospital of Traditional Chinese Medicine

• Yabin Sun, Doctor · The First Hospital of Jilin University

• Liming Tao, Doctor · The Second Hospital of Anhui Medical University

• Hongjian Ma, Doctor · Aier Eye Hospital, Guangzhou

• Yaohong Wu, Doctor · Second Hospital of Shanxi Medical University

• Jian Guo, Doctor · First Affiliated Hospital of Fujian Medical University

• Xiaoling Luo, Doctor · Shenzhen People's Hospital

• Qiuhong Liu, Doctor · The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

• Xinquan Liu, Doctor · Shanghai University of Traditional Chinese Medicine

• Lifei Wang, Doctor · Hebei Provincial Eye Hospital

• Dan Zhu, Doctor · The Affiliated Hospital of Inner Mongolia Medical University

• Xuemei Pan, Master · The Affiliated Eye Hospital of Shandong University of Chinese Medicine

• Yanfei Qiu, Doctor · Pingxiang People's Hospital

• Zhen Zhang, Doctor · Xuzhou Central Hospital

• Jingbo Li, Doctor · Luoyang Third People's Hospital

• Xinyan Xu, Master · Weifang Eye Hospital

• Lan Li, Master · The First People's Hospital of Kunming

• Hongxia Yang, Bachelor · Jinzhong First People's Hospital

• Miaoqin Wu, Doctor · Zhejiang Provincial People's Hospital

• Zhaozeng Lu, Doctor · Huashan Hospital

• Gangfeng Cui, Doctor · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

• Quanyong Yi, Doctor · Ningbo Eye Hospital

• Ruifeng Wang, Doctor · The Second People's Hospital of Zhengzhou

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-07

Primary Completion

2025-04-22

Completion

2025-04-22

Countries

• China

Study Locations