Actively Recruiting
Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy
Led by Chigenovo Co., Ltd · Updated on 2025-01-03
62
Participants Needed
8
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, randomized and controlled phase 3 clinical trial.
CONDITIONS
Official Title
Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the trial purpose and requirements, agree to participate voluntarily, and can complete all procedures
- Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age 18 years or older
- Genetic testing confirming biallelic CYP4V2 mutations without other eye genetic diseases
- Best-corrected visual acuity between 5 and 60 ETDRS letters
You will not qualify if you...
- Study eye has or had macular lesions like macular hole or neovascularization, glaucoma, diabetic retinopathy, or other eye diseases that affect surgery or study results
- Study eye had retinal reattachment or vitrectomy surgery
- Study eye had any intraocular surgery such as phacoemulsification within 3 months before enrollment
- Previous gene therapy or stem cell treatment in either eye for BCD or other eye diseases
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
3
The First Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Not Yet Recruiting
4
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
5
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
7
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
8
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
J
Jinlu Zhang, MD
CONTACT
T
Tingting Wu, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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