Clinical Trial

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

Recruiting Phase 3
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Summary
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).
Trial Details
NCT Number NCT07515079
Lead Sponsor Bio-Thera Solutions
Conditions Diabetic Macular Edema (DME)
Enrollment 406 participants
Start Date 2024-10-09
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-07