Phase
Condition
Retinitis Pigmentosa
Retina
Treatment
VGR-R01
Clinical Study ID
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Able to provide informed consent and comply with requirements of the study;
≥18 years and <70 years of age;
Confirmed diagnosis of Bietti Crystalline Dystrophy and molecular diagnosis ofCYP4V2 mutations (homozygotes or compound heterozygotes);
Hand Motion ≤ BCVA ≤ 60 ETDRS letters in the study eye;
Exclusion
Key Exclusion Criteria:
Have insufficient viable retinal photoreceptor cells based on investigator'sdecision;
Have current ocular or periocular infections, or endophthalmitis;
Have any significant ocular disease/disorder other than BCD, including age-relatedmacular degeneration, diabetic retinopathy, optic neuropathy, significant lensopacity, glaucoma, uveitis, retinal detachment, etc;
Have intraocular surgery history except cataract surgery in the study eye;
Have or potentially require of systemic medications that may cause eye injure;
Have contraindications for corticosteroids or immunosuppressant;
Unwilling or unable to have the planned follow-up;
Abnormal coagulation function or other clinically significant abnormal laboratoryresults;
Have malignancies or history of malignancies;
History of immunodeficiency (acquired or congenital); Other protocol definedInclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Shanghai Vitalgen Biopharma Co.,Ltd.
Shanghai, Shanghai
ChinaSite Not Available
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