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ACTIVE NOT RECRUITING
NCT06699108
PHASE3

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

Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

VGR-R01

Subretinal injection of VGR-R01 (0.1 mL)

Locations (1)

Shanghai Vitalgen Biopharma Co.,Ltd.

Shanghai, Shanghai Municipality, China