Clinical Trials in China / NCT06743646
Active, not recruiting
Phase 3
Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy
NCT06743646 · tracked via the Priya Life Science China tracker
Condition(s) studied
Bietti Crystalline Corneoretinal DystrophyBietti Crystalline Dystrophy
Study summary
This is a multi-center, randomized and controlled phase 3 clinical trial.
Eligibility
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;
Primary outcome measure(s)
- Proportion of study eyes with a ≥15-letter improvement from baseline in BCVA — From baseline to Week 52
Best corrected visual acuity (BCVA) will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A 15-letter improvement over the baseline is clinical meaningful.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | |
| Henan Provincial People's Hospital | Zhengzhou | Henan | |
| West China Hospital of Sichuan University | Chengdu | Sichuan | |
| Tianjin Medical University Eye Hospital | Tianjin | Tianjin Municipality |
More Chigenovo Co., Ltd trials in China
Safety and Efficacy of ZVS101e in Patients With Bietti 's Crystalline Dystrophy
Active, not recruiting
ZVS101e in Patients With Bietti's Crystalline Dystrophy
Starting soon
Compassionate Administration of ZVS101e for Extended Treatment
Enrolling by invitation
Other trials for the same condition
A Safety Study of Contralateral Eye Dosing of VGR-R01 in Participants With Bietti's Crystalline Dystrophy (BCD)
Starting soon
Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy Subjects
Active, not recruiting
Study to Evaluate the Efficacy and Safety of VGR-R01 Gene Therapy in Patients With Bietti Crystalline Dystrophy
Active, not recruiting
ZVS101e in Patients With Bietti's Crystalline Dystrophy
Starting soon
Compassionate Administration of ZVS101e for Extended Treatment
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06743646 on ClinicalTrials.gov ↗ ← All trials in China