The Safety and Efficacy of ZVS106e in the Treatment of IRDs Caused by Biallelic Mutations in ABCA4
NCT07241169 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-04-16
Summary
To evaluate the preliminary safety of monocular and single subretinal injection of ZVS106e injection in the treatment of patients with hereditary retinal degeneration (ABCA4-IRDS) caused by ABCA4 biallelic mutations.
Conditions
- Stargardt
Interventions
- DRUG
-
ZVS106e
ZVS106e is A colorless, clear and transparent liquid, containing two active ingredients, ZVS106E-A and ZVS106E-B. The viral vectors used for both active ingredients are rAAV8
Sponsors & Collaborators
-
Chigenovo Co., Ltd
collaborator NETWORK -
Zhongshan Ophthalmic Center, Sun Yat-sen University
lead OTHER
Principal Investigators
-
qingjiong zhang, M.D · PI
-
lin Lv, M.D · PI
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-29
- Primary Completion
- 2028-11-30
- Completion
- 2028-12-30
Countries
- China
Study Locations
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