Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05399069
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years and \<80 years of age;
2. Confirmed diagnosis of Bietti Crystalline Dystrophy;
3. Molecular diagnosis of CYP4v2 mutations (homozygotes or compound heterozygotes);
4. BCVA ≤ 20/200 in the study eye;
5. -8 D \<diopters\< +8 D, 21 mm \< axial lengths ≤ 28 mm in the study eye;
6. Normal liver function and renal function；
7. Agree to use reliable barrier contraception for 1 year after administration of VGR-R01;
8. Able to provide informed consent and comply with requirements of the study. -
Exclusion Criteria:
1. Have insufficient viable retinal photoreceptor cells based on investigator's decision;
2. Have current ocular or periocular infections, or endophthalmitis;
3. Have any significant ocular disease/disorder other than BCD, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc;
4. Have intraocular surgery history except cataract surgery in the study eye;
5. Prior medications which may interfere with the interpretation of study endpoints within six months before screening, eg. anti-VEGF drugs;
6. Have or potentially require of systemic medications that may cause eye injure;
7. Live attenuated vaccines is expected to be required during the study;
8. Participation in a clinical study with an investigational drug or medical device within three months before enrollment;
9. History of allergy or sensitivity to investigational drug, medications planned for use in the study;
10. Use of anticoagulants, or after 10 days cessation of anti-platelet agents the platelet function does not recover;
11. Use of any corticosteroids, other immunosuppressive drug(s) or antipsychotic drugs (eg. antidepressant, etc.) within 3 months prior to enrollment;
12. Have contraindications for corticosteroids or immunosuppressant;
13. Have complicating systemic diseases that would preclude the planned follow-up;
14. Abnormal coagulation function or other clinically significant abnormal laboratory results;
15. Have malignancies or history of malignancies;
16. History of immunodeficiency (acquired or congenital);
17. Females in lactation period;
18. Have a history of alcohol or illicit drug addiction;
19. Unable or unwilling to comply with the schedule of visits. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05399069
Study Brief:
Protocol Section:
NCT05399069