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ACTIVE NOT RECRUITING
NCT05832684
PHASE1/PHASE2

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

Sponsor: Chigenovo Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-02-20

Completion Date

2028-12

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

DRUG

ZVS101e

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

Locations (3)

Peking University Third Hospital

Beijing, Beijing Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China