NCT05714904

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

An Exploratory Clinical Study on Single Subretinal Injection of ZVS101e (rAAV2/8-hCYP4V2) Into Eyes With Bietti's Crystalline Dystrophy (BCD)

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of an adeno-associated virus vector expressing CYP4V2 in patients with Bietti's crystalline dystrophy (BCD).

Detailed description

This is a single-arm, open-label, and single-center study of ZVS101e in patients with BCD. A total of 6 participants will be enrolled. A retinal surgeon will administer the vector by subretinal injection. Safety, efficacy and vector shedding characteristics of ZVS101e are then measured over 2 years.

Conditions

• Bietti's Crystalline Dystrophy

Interventions

Type	Name	Description
DRUG	ZVS101e	ZVS101e is developed by Chigenovo Co., Ltd., it contains recombinant adeno-associated virus serotype 8 (rAAV8) vectors which carry human CYP4V2 gene.

Timeline

• Start date: 2022-09-23
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2023-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: China