Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714904
Status:
RECRUITING
Last Update Posted:
2023-02-06
First Post:
2022-12-13
Brief Title:
Safety and Tolerability of ZVS101e in Patients With Bietti s Crystalline Dystrophy
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
An Exploratory Clinical Study on Single Subretinal Injection of ZVS101e rAAV28-hCYP4V2 Into Eyes With Biettis Crystalline Dystrophy BCD
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety and tolerability of an adeno-associated virus vector expressing CYP4V2 in patients with Biettis crystalline dystrophy BCD
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None