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ADX-038 for geographic atrophy due to age-related macular degeneration

A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Phase 2 Interventional ADARx Pharmaceuticals, Inc. · NCT06990269

This phase 2 study will test whether ADX-038 can slow geographic atrophy in people with age-related macular degeneration compared with placebo while monitoring safety and drug levels.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages60 Years and up
SexAll
SponsorADARx Pharmaceuticals, Inc. Industry-sponsored
Locations24 sites (Gilbert, Arizona and 23 other locations)
Trial IDNCT06990269 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled phase 2 trial compares ADX-038 with placebo in participants who have geographic atrophy (GA) secondary to age-related macular degeneration. Participants meeting lesion size and imaging quality criteria are assigned to receive ADX-038 or placebo and return for scheduled clinic visits with retinal imaging and vision testing to track GA lesion growth and function. The study also collects safety data and measures pharmacokinetics and pharmacodynamics to understand drug behavior and biological effects. Completion of specified meningococcal and pneumococcal vaccinations and adherence to visit schedules are required for participation.

Who should consider this trial

Good fit: Adults with GA secondary to AMD who have lesion areas between 2.5 and 12.5 mm², clear ocular media and reliable fixation for imaging, and who can complete required vaccinations and clinic visits are appropriate candidates.

Not a fit: Patients with GA from causes other than AMD, active ocular disease that affects vision, prior intravitreal complement inhibitor use, known complement deficiency, active infections, significant liver injury, or a history of choroidal neovascularization are unlikely to receive benefit from this study.

Why it matters

Potential benefit: If successful, ADX-038 could slow enlargement of GA lesions and help preserve vision for a longer time.

How similar studies have performed: Other programs targeting the complement pathway have shown that complement inhibition can slow GA progression in some trials and led to regulatory approvals, although approaches in this area remain under active investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Clinical diagnosis of GA of the macula secondary to AMD
* GA lesions between 2.5 and 12.5 mm2 at screening
* Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
* Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol

Exclusion Criteria:

* Has GA secondary to causes other than AMD
* Has active ocular disease that compromises or confounds visual function
* History of surgery for retinal detachment
* Has ocular condition other than GA secondary to AMD
* Use of intravitreal complement inhibitors in study eye
* Hereditary or acquired complement deficiency
* Active viral, bacterial or fungal infection
* Liver injury as evidenced by abnormal liver function tests
* Donating blood
* History of choroidal neovascularization in the study eye

Where this trial is running

Gilbert, Arizona and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Geographic Atrophy Secondary to Age-related Macular Degeneration
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.