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Active Not Recruiting NCT06743646

Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

Conditions: Bietti Crystalline Corneoretinal Dystrophy, Bietti Crystalline Dystrophy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 62
Sponsor: Chigenovo Co., Ltd

Location: Peking University Third Hospital Beijing Beijing Municipality

Summary

This is a multi-center, randomized and controlled phase 3 clinical trial.

Eligibility Criteria

Inclusion Criteria: 1. All of the following inclusion criteria should be met for enrollment into the trial: 2. 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; 3. Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age≥18 years ; 4. Genetic testing confirmed biallelic CYP4V2 mutations without other ophthalmic genetic diseases; 5. Best-corrected visual acuity of 5-60 ETDRS letters. Exclusion Criteria: 1. 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 2. The study eye had received the following intraocular surgical treatments: retinal reattachment, vitrectomy; 3. The study eye had received any intraocular surgery, such as phacoemulsification 3 months prior to enrollment; 4. 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; 5. Pregnant or lactating women;

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06743646). StuddyBuddy aggregates publicly available trial information.