Clinical Study of the Safety and Efficacy of BAT5906 Injection
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the
efficacy and safety of BAT5906 injection in patients with diabetic macular edema. BAT5906's
phase I study on w-AMD shows that it is safe from 0.3-4.0 mg, and the higher dose (2.5 mg and
4 mg) may maintain the effect for longer; the same target drugs (such as brolucizumab and
Abecip ) It has also been found in clinical studies that high doses can extend the dosing
interval and reduce the dosing frequency. Therefore, in this study, two safe and effective
doses were selected, and the optimal clinical effective dose and frequency of BAT5906 in DME
were initially explored.