Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy
NCT ID: NCT06743646
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
62 participants
INTERVENTIONAL
2024-12-27
2030-06-30
Brief Summary
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Detailed Description
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Participants in the control group will receive no treatment during the first 52 weeks of enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment group
Each Participant in this group will receive a unilateral subretinal injection of ZVS101e in the study eye
ZVS101e
subretinal injection of ZVS101e
Control group
Participants in the control group will receive no treatment
No interventions assigned to this group
Interventions
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ZVS101e
subretinal injection of ZVS101e
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
3. Clinical diagnosis of Bietti's crystalline dystrophy (BCD), ageā„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
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;
18 Years
ALL
No
Sponsors
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Chigenovo Co., Ltd
NETWORK
Responsible Party
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Principal Investigators
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Jinlu Zhang, MD
Role: STUDY_DIRECTOR
Chigenovo Co., Ltd
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Tingting Wu, BS
Role: primary
References
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Jia R, Meng X, Chen S, Zhang F, Du J, Liu X, Yang L. AAV-mediated gene-replacement therapy restores viability of BCD patient iPSC derived RPE cells and vision of Cyp4v3 knockout mice. Hum Mol Genet. 2023 Jan 1;32(1):122-138. doi: 10.1093/hmg/ddac181.
Wang J, Zhang J, Yu S, Li H, Chen S, Luo J, Wang H, Guan Y, Zhang H, Yin S, Wang H, Li H, Liu J, Zhu J, Yang Q, Sha Y, Zhang C, Yang Y, Yang X, Zhang X, Zhao X, Wang L, Yang L, Wei W. Gene replacement therapy in Bietti crystalline corneoretinal dystrophy: an open-label, single-arm, exploratory trial. Signal Transduct Target Ther. 2024 Apr 24;9(1):95. doi: 10.1038/s41392-024-01806-3.
Other Identifiers
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ZYA-2024-001
Identifier Type: -
Identifier Source: org_study_id
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