NCT06743646

Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

A Multicenter, Randomized，Controlled，Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of ZVS101e Administered as a Single Subretinal Injection in Subjects With Bietti's Crystalline Dystrophy (BCD)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Chigenovo Co., Ltd · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized and controlled phase 3 clinical trial.

Detailed description

Subjects who have signed the written informed consent form and who were eligible for enrollment after screening will be randomly assigned to the treatment group or untreated control group. Each Participant in the treatment group will receive a unilateral subretinal injection of ZVS101e in the study eye. Participants in the control group will receive no treatment during the first 52 weeks of enrollment.

Conditions

• Bietti Crystalline Corneoretinal Dystrophy
• Bietti Crystalline Dystrophy

Interventions

Type	Name	Description
DRUG	ZVS101e	subretinal injection of ZVS101e

Timeline

• Start date: 2024-12-27
• Primary completion: 2026-06-30
• Completion: 2030-06-30
• First posted: 2024-12-20
• Last updated: 2025-01-03

Locations

8 sites across 1 country: China