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Study to Evaluate the Efficacy and Safety of VGR-R01 Gene Therapy in Patients With Bietti Crystalline Dystrophy
Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.
Summary
This is a phase 3 study to evaluate the efficacy and safety of VGR-R01 in subjects with Bietti Crystalline Dystrophy. This is a multicenter, randomized controlled study which will enroll 45 subjects.
Official title: A Multi-Center, Randomized, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VGR-R01 in Subjects With Bietti Crystalline Dystrophy
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-12-13
Completion Date
2027-06-30
Last Updated
2025-12-24
Healthy Volunteers
No
Interventions
VGR-R01
Subretinal injection of VGR-R01 (0.1 mL)
Locations (1)
Shanghai Vitalgen Biopharma Co.,Ltd.
Shanghai, Shanghai Municipality, China