MedTrace Logo

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

NCT07515079 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-04-07

No results posted yet for this study

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

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

Principal Investigators

  • Xiaodong Sun · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07515079 on ClinicalTrials.gov