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A Safety Study of Contralateral Eye Dosing of VGR-R01 in Participants With Bietti's Crystalline Dystrophy (BCD)
Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.
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.
Official title: A Clinical Study Evaluating Subretinal Injection of VGR-R01 in the Contralateral Eye of Participants With Bietti's Crystalline Dystrophy Who Had Received VGR-R01 Administration
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-06-01
Completion Date
2031-07-31
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
VGR-R01
CYP4v2-coding gene delivered by AAV vector
Locations (2)
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Shanghai General Hospital (Shanghai First People's Hospital)
Shanghai, Shanghai Municipality, China