NCT04772105

Clinical Study of the Safety and Efficacy of BAT5906 Injection

Phase Ib/IIa Clinical Study of the Safety and Efficacy of BAT5906 Injection in Patients With Diabetic Macular Edema With Multiple Changes of Intravitreal Two Doses

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	2.5mg of BAT5906	Specification: 2.5mg of BAT5906
DRUG	4.0mg of BAT5906	Specification: 4.0mg of BAT5906

Timeline

• Start date: 2020-10-16
• Primary completion: 2023-11-06
• Completion: 2023-11-06
• First posted: 2021-02-26
• Last updated: 2024-04-16

Locations

19 sites across 1 country: China