NCT05141994

Clinical Study on the Efficacy and Safety of BAT5906 Injection

Phase II Clinical Study on the Efficacy and Safety of BAT5906 Injection in the Vitreous Age-related Macular Degeneration Patients With Two Repeated Intravitreal Dose

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs with the same target (such as brolucizumab and Abecip) have also been found in clinical studies High doses can extend the interval and reduce the frequency of administration. Therefore, in this study, two doses with better safety and efficacy were selected, once every 4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary exploration of the best clinical effective dose and replacement frequency

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	2.5mg of BAT5906	Specification: 2.5mg of BAT5906
DRUG	4mg of BAT5906	Specification: 4mg of BAT5906

Timeline

• Start date: 2020-08-26
• Primary completion: 2022-09-06
• Completion: 2022-09-06
• First posted: 2021-12-02
• Last updated: 2024-04-16

Locations

16 sites across 1 country: China