Condition: Diabetic Macular Edema (DME) · Sponsor: Bio-Thera Solutions
A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).
This description comes directly from the study's public registry record.
Xizhen Hu · 020-32203220 · xzhu@bio-thera.com
Zhaohe Wang, Ph.D
Always discuss trial participation with your own doctor first.
| Beijing Aier Yingzhi Eye Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Peking University Third Hospital | Beijing, Beijing Municipality, China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Recruiting |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Recruiting |
| Gansu Provincial People's Hospital | Lanzhou, Gansu, China | Active Not Recruiting |
| The Second Hospital of Lanzhou University | Lanzhou, Gansu, China | Recruiting |
| Guangzhou Aier Eye Hospital | Guangzhou, Guangdong, China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou, Guangdong, China | Recruiting |
| Shantou University-The Chinese University of Hong Kong Joint Shantou International Eye Center | Shantou, Guangdong, China | Recruiting |
| Shenzhen People's Hospital | Shenzhen, Guangdong, China | Recruiting |
| Guangxi Zhuang Autonomous Region People's Hospital | Nanning, Guangxi, China | Recruiting |
| Zunyi Medical University Affiliated Hospital | Zunyi, Guizhou, China | Recruiting |
+ 38 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07515079