Clinical Trial

Study to Evaluate the Efficacy and Safety of VGR-R01 Gene Therapy in Patients With Bietti Crystalline Dystrophy

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-19.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-12-17
Trial Details
NCT Number NCT06699108
Lead Sponsor Shanghai Vitalgen BioPharma Co., Ltd.
Conditions Bietti Crystalline Dystrophy, Inherited Retinal Diseases
Enrollment 45 participants
Start Date 2024-12-13
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-24