Safety and Efficacy Study of Novel Gene Therapy AGX-08 for Geographic Atrophy
NCT07602127 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-05-22
Summary
This is AGX-08's safety, tolerability, and efficacy in Geographic Atrophy first-in-human study. This trial is meant to evaluate the safety and efficacy of AGX-08 in Geographic Atrophy patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.
Conditions
Interventions
- DRUG
-
AGX-08-L
rAAV2.AG-eNCRV intravitreal injection of low dose
- DRUG
-
AGX-08-M
rAAV2.AG-eNCRV intravitreal injection of middle dose
- DRUG
-
AGX-08-H
rAAV2.AG-eNCRV intravitreal injection of high dose
- PROCEDURE
-
AGX-08-S
sham intravitreal injection of AGX-08 (not actual injection)
Sponsors & Collaborators
-
Zhongmou Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-12-30
- Completion
- 2029-12-30
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