NCT05832684

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

A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of ZVS101e Administered as a Single Monocular Subretinal Injection in Subjects With Bietti's Crystalline Dystrophy (BCD)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chigenovo Co., Ltd · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of ZVS101e administered by subretinal injection in subjects with Bietti's crystalline dystrophy (BCD) and to select the optimal effective dose.

Detailed description

This is a single-arm, open-label, and multi-center study of ZVS101e in patients with BCD. Up to 24 subjects are expected to be enrolled. Each participant will receive ZVS101e by subretinal injection in one eye on a single occasion. Safety, efficacy and vector shedding characteristics of ZVS101e are then measured over 180 days. Participants will subsequently enter a long-term follow-up study over a 4.5-year period.

Conditions

• Bietti's Crystalline Dystrophy

Interventions

Type	Name	Description
DRUG	ZVS101e	ZVS101e contains recombinant adeno-associated virus serotype 8 (rAAV8) vectors which carry human wild type CYP4V2 gene.

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-12-01
• Completion: 2028-12-01
• First posted: 2023-04-27
• Last updated: 2024-08-28

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study