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)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multi-center, randomized and controlled phase 3 clinical trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All of the following inclusion criteria should be met for enrollment into the trial:
• 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.
Locations
Other Locations
China
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Zhongshan Ophthalmic Center, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Haerbin
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Eye Hospital, Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Jinlu Zhang, MD
zhangjinlu@chinagene.cc
+86-15810570898
Backup
Tingting Wu, BS
wutingting@chinagene.cc
+86-18500191916
Time Frame
Start Date: 2024-12-27
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 62
Treatments
Experimental: Treatment group
Each Participant in this group will receive a unilateral subretinal injection of ZVS101e in the study eye
No_intervention: Control group
Participants in the control group will receive no treatment
Related Therapeutic Areas
Sponsors
Leads: Chigenovo Co., Ltd