RecruitingPhase 3NCT06743646
Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy
A Multicenter, Randomized，Controlled，Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of ZVS101e Administered as a Single Subretinal Injection in Subjects With Bietti's Crystalline Dystrophy (BCD)
Sponsor
Chigenovo Co., Ltd
Enrollment
62 participants
Start Date
Dec 27, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This is a multi-center, randomized and controlled phase 3 clinical trial.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form, and be able to complete all trial procedures as required by the protocol;
- Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age≥18 years ;
- Genetic testing confirmed biallelic CYP4V2 mutations without other ophthalmic genetic diseases;
- Best-corrected visual acuity of 5-60 ETDRS letters.
Exclusion Criteria5
- The study eye has or has had macular lesions such as macular hole or macular neovascularization; glaucoma, diabetic retinopathy, or any other ocular disease that may preclude surgery or interfere with interpretation of the study endpoints
- The study eye had received the following intraocular surgical treatments: retinal reattachment, vitrectomy;
- The study eye had received any intraocular surgery, such as phacoemulsification 3 months prior to enrollment;
- Previously treatment of either eye with gene therapy or stem cell therapy for BCD and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy;
- Pregnant or lactating women;
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Interventions
DRUGZVS101e
subretinal injection of ZVS101e
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06743646