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COMPLETED
NCT04772105
PHASE1/PHASE2

Study of Two Multiple Intravitreal Doses of BAT5906 for Safety and Efficacy in Patients With Diabetic Macular Edema

Sponsor: Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the efficacy and safety of BAT5906 injection in patients with diabetic macular edema. BAT5906's phase I study on w-AMD shows that it is safe from 0.3-4.0 mg, and the higher dose (2.5 mg and 4 mg) may maintain the anti-VEGF effect for a longer time just like the same target drugs (such as brolucizumab and Abecip ) It has also been found in clinical studies that high doses can extend the dosing interval and reduce the dosing frequency. Therefore, in this study, two safe and effective doses were selected, and the optimal clinical effective dose and frequency of BAT5906 in DME were initially explored.

Official title: Phase Ib/IIa Study to Evaluate the Safety and Efficacy of Intravitreal Administration of Two Doses of BAT5906 Injection With Multiple Dosing Regimens in Patients With Diabetic Macular Edema

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2020-10-16

Completion Date

2023-11-06

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

2.5mg of BAT5906

Specification: 2.5mg of BAT5906

DRUG

4.0mg of BAT5906

Specification: 4.0mg of BAT5906

Locations (19)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijiang, Beijing Municipality, China

Eye Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Peking University First Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Henan Provincial Eye Hospital

Henan, China

Jieyang People's Hospital

Jieyang, China

The First Hospital of Jilin University

Jilin City, China

The Affiliated Eye Hospital of Nanchang University

Nanchang, China

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China

Affiliated Hospital of Nantong University

Nantong, China

Affiliated Hospital of Qingdao University

Qingdao, China

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, China

West China Hospital of Sichuan University

Sichuan, China

Wenzhou Medical University Affiliated Optometry Hospital

Wenzhou, China

The Second Xiangya Hospital of Central South University

Xiangya, China

Xiangya Hospital Central South University

Xiangya, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China