NCT07515079

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

A Multicenter, Randomized, Double-Blind Phase III Clinical Study Comparing the Efficacy and Safety of BAT5906 Versus Ranibizumab (Lucentis®) in Patients With Diabetic Macular Edema (DME)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	BAT5906 injection	4.0 mg/eye/time, 50 μl, intravitreal injection
DRUG	Lucentis	0.5 mg/eye/time, 50 μl, intravitreal injection

Timeline

• Start date: 2024-10-09
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

50 sites across 1 country: China