Safety Study of rAAV2/8-hCYP4V2 in Patients With Bietti's Crystalline Dystrophy (BCD)

Bietti's Crystalline Dystrophy Clinical Trial

Official title:
Safety Trial of rAAV2/8-hCYP4V2 Gene Replacement Therapy Drug Administered as a Single Subretinal Injection in Patients With Bietti's Crystalline Dystrophy (BCD)

Status Recruiting

Clinical Trial Summary

Primary Objectives: To evaluate the safety of rAAV2/8-hCYP4V2 gene replacement therapy drug administered as a single subretinal injection in patients with Bietti's Crystalline Dystrophy (BCD). Secondary Objectives: To preliminarily explore the clinical effectiveness of rAAV2/8-hCYP4V2 gene replacement therapy drugs.

Clinical Trial Description

This is a single-arm, open-label, and single-center study of ZVS101e in patients with BCD. A total of 12 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04722107
Study type	Interventional
Source	Beijing Tongren Hospital
Contact	wenbin Wei, Doctor
Phone	13701255115
Email	tr_weiwenbin@163.com
Status	Recruiting
Phase	Early Phase 1
Start date	April 21, 2021
Completion date	April 29, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05714904` - Safety and Tolerability of ZVS101e in Patients With Bietti 's Crystalline Dystrophy	Early Phase 1
Active, not recruiting	`NCT06302608` - Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy	Early Phase 1
Recruiting	`NCT05832684` - Safety and Efficacy of ZVS101e in Patients With Bietti 's Crystalline Dystrophy	Phase 1/Phase 2