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

Bietti's Crystalline Dystrophy Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05714904
Study type	Interventional
Source	Peking University Third Hospital
Contact	Hongliang Dou, MD
Phone	010-82266563
Email	douhongliang3736@sina.com
Status	Recruiting
Phase	Early Phase 1
Start date	September 23, 2022
Completion date	March 31, 2025

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See also
Status	Clinical Trial	Phase
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
Recruiting	`NCT04722107` - Safety Study of rAAV2/8-hCYP4V2 in Patients With Bietti's Crystalline Dystrophy (BCD)	Early Phase 1