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Clinical Trial Report

Gene Therapy Trial Report

Summary

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


NCTID NCT05832684 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Bietti Crystalline Dystrophy
Disease Ontology Term DOID:0050664
Compound Name ZVS101e
Compound Description rAAV2/8-hCYP4V2
Sponsor Chigenovo Co., Ltd
Funder Type Network
Recruitment Status
Active not recruiting
Enrollment Count 24
Results Posted Not Available

Therapy Information


Target Gene/Variant CYP4V2
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Subretinal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV2/8
Editor Type none
Dose 1 7.5E10 vg
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2023-04-02
Completion Date 2028-12
Last Update 2024-08-28

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 3
Locations China

Regulatory Information


Has US IND True
FDA Designations
Recent Updates

Resources/Links