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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04772105
Study type Interventional
Source Bio-Thera Solutions
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 16, 2020
Completion date November 6, 2023

See also
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