A Safety Study of Contralateral Eye Dosing of VGR-R01 in Participants With Bietti's Crystalline Dystrophy (BCD)
NCT07586306 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-05-14
Summary
This is a multi-centre, single- arm, non-randomized, open-label phase 1/2 clinical trial which enables dosing of the fellow eyes of patients who received VGR-R01 administration in previous studies.
Conditions
- Bietti Crystalline Dystrophy
Interventions
- BIOLOGICAL
-
VGR-R01
CYP4v2-coding gene delivered by AAV vector
Sponsors & Collaborators
-
Shanghai Vitalgen BioPharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Wenbin Wei · Beijing Tongren Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2027-07-31
- Completion
- 2031-07-31
Countries
- China
Study Locations
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