drugset / Trial / NCT05439629
Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT5906 | Unknown | 4 mg | Intravitreal |
| Comparator | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |