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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.
Full description
VGR-R01 is a novel AAV vector carrying the human CYP4v2 coding sequence. This study is intended to assess the efficacy of VGR-R01 in subjects with Bietti crystalline dystrophy (BCD) based on the change from baseline in best corrected visual acuity (BCVA) of the study eyes.
30 subjects will be enrolled in the intervention group and will receive monocular administration of VGR-R01, and 15 subjects in the control group will not receive any intervention. After completion of the trial, the untreated eyes will receive administration of VGR-R01 in subsequent clinical trial.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Primary purpose
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Interventional model
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45 participants in 2 patient groups
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Central trial contact
Shanshan Li
Data sourced from clinicaltrials.gov
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