Safety and Efficacy Study of Novel Gene Therapy AGX-08 for Geographic Atrophy
ConditionGeographic Atrophy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorZhongmou Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
Clinically confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD);
Age ≥ 50 years, regardless of sex;
Best-corrected visual acuity (BCVA) in the study eye measured using the ETDRS chart at a starting distance of 4 meters must be ≤77 letters (Snellen equivalent ≤20/63), with vision no worse than light perception; the fellow eye must not have better visual acuity than the study eye;
GA lesion size between 2.5 and 17.5 mm² with clearly defined borders. For multifocal GA, at least one lesion must be ≥1.25 mm² (0.5 disc area) to ensure measurable efficacy assessment;
Disqualifiers
GA caused by conditions other than AMD (e.g., Stargardt disease, cone-rod dystrophy, or other inherited macular dystrophies);
Aphakia in the study eye, or cataract surgery/YAG capsulotomy within 3 months prior to screening;
Refractive status or axial length outside the following range: spherical equivalent between -6.00D and +5.00D, and axial length between 21 mm and 26 mm;
Two baseline BCVA measurements (ETDRS) taken at least 14 days apart during screening differ by >30%;
Trial design
Treatments tested in this trial
- AGX-08-L
- AGX-08-M
- AGX-08-H
- AGX-08-S
Treatment groups
24 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov