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

NCT05832684 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-28

No results posted yet for this study

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.

Conditions

  • Bietti's Crystalline Dystrophy

Interventions

DRUG

ZVS101e

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

Sponsors & Collaborators

  • Chigenovo Co., Ltd

    lead NETWORK

Principal Investigators

  • Xiaorong Li, MD · Tianjin Medical University Eye Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2024-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832684 on ClinicalTrials.gov