drugset / Trial / NCT05439629

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

NCT05439629

Phase 3 Completed 488 enrolled Bio-Thera Solutions
RandomizedParallel-groupTriple-blindTreatment

Summary

A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled. Qualified subjects were divided into experimental group and control group in a 1:1 ratio, and stratified randomized according to the letter value of baseline period and whether the eyes had received anti-VEGF drug treatment. The experimental group received BAT5906 injection. The control group received Lucentis® treatment. Only 1 eye per subject was included in this study.

Timeline

Start
2022-07-07
Primary completion
2025-04-22
Completion
2025-04-22

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT5906 Unknown 4 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal