Retina Consultants San Diego Opens Enrollment in GA Clinical Trial With ADARx Pharmaceuticals
Retina Consultants San Diego (RCSD) has been selected to participate in a Phase 2 clinical trial evaluating ADX-038 in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). RCSD is one of the few San Diego-area sites joining this important study aimed at treating vision loss in patients with GA due to AMD.
A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to AMD
This trial (Study ID: ADX-038-202, NCT06990269) investigates ADX-038, an investigational siRNA therapeutic designed to target complement pathway-mediated disease processes that contribute to the progression of geographic atrophy. The study will compare ADX-038 versus placebo to evaluate its effect on slowing retinal tissue loss and preserving vision in adults with GA secondary to AMD.
About ADX-038
ADX-038 is a novel small interfering RNA (siRNA) molecule intended to reduce activity within the complement cascade—a pathway implicated in the degenerative process of geographic atrophy. By targeting a specific component of this pathway, ADX-038 may help slow the enlargement of atrophic lesions and potentially preserve retinal structure and function.
About the Phase 2 ADX-038 Clinical Trial
Study Phase: Phase 2 interventional
Status: Not yet recruiting at select sites
Sponsor: ADARx Pharmaceuticals, Inc.
Estimated Enrollment: 240 participants
Study Start: Late 2025
Primary Completion: 2027
Study Completion: 2027
Study Design
This is a randomized, masked, placebo-controlled, parallel assignment trial to assess the efficacy and safety of subcutaneously administered ADX-038 compared to placebo in participants with geographic atrophy due to AMD. Participants are randomized in a 2:1 ratio to receive ADX-038 or placebo.
Key Inclusion Criteria
Participants must meet all of the following:
- Clinical diagnosis of geographic atrophy secondary to AMD
- GA lesion size within a specified range on imaging at screening
- Clear ocular media and fixation sufficient for high-quality retinal imaging
- Ability to comply with study visits and procedures (including required vaccinations)
Key Exclusion Criteria
Exclusions include GA due to non-AMD causes, active ocular disease confounding visual assessment, previous intravitreal complement inhibitor use in the study eye, significant liver dysfunction, and other ocular or systemic conditions as defined in the protocol.
Study Arms & Interventions
ADX-038 Arm:
Participants receive systemic ADX-038 siRNA according to the trial dosing schedule.
Placebo Arm:
Participants receive matched placebo (saline)
Outcome Measures
Primary Outcome:
Preservation of key retinal layers and reduced progression of geographic atrophy lesions at 12 months (measured by change in EZ layer loss area).
Secondary Outcomes:
- Additional structural and functional retinal measures
- Safety, tolerability, pharmacokinetics, and pharmacodynamics of ADX-038
View full study details on clinicaltrials.gov
Interested in joining?
Contact RCSD today to learn more about eligibility and enrollment opportunities for the ADX-038 Phase 2 clinical trial.