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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ADARx Clinical Site
  Gilbert, Arizona, United States Recruiting
• ADARx Clinical Site
  Phoenix, Arizona, United States Recruiting
• ADARx Clinical Site
  Bakersfield, California, United States Recruiting
• ADARx Clinical Site
  Beverly Hills, California, United States Recruiting
• ADARx Clinical Site
  Huntington Beach, California, United States Recruiting
• ADARx Clinical Site
  Poway, California, United States Recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nali Castillo
• Email: info@adarx.com
• Phone: 877-232-7974

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Transcorneal electrical stimulation to slow geographic atrophy

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• FWY003 versus placebo for geographic atrophy from age-related macular degeneration

  This study will test whether injections of FWY003 can slow the growth of geographic atrophy in people aged 50 and older with AMD.

  Recruiting at 65 sites Phase 2 Novartis · Huntington Beach, California and 64 other locations · NCT07441642

• One-time subretinal CTx001 injection for geographic atrophy from AMD

  This trial will try a single subretinal injection of CTx001 to see if it is safe and helps people with bilateral geographic atrophy from age-related macular degeneration.

  Recruiting at 8 sites Phase 1/2 Complement Therapeutics · Carmel, Indiana and 7 other locations · NCT07392255

• APL-3007 combined with Syfovre (pegcetacoplan) for geographic atrophy from age-related macular degeneration

  This trial will test whether adding APL-3007 to ongoing Syfovre (pegcetacoplan) injections can slow geographic atrophy progression in people aged 60 and older already receiving Syfovre.

  Recruiting at 78 sites Phase 2 Apellis Pharmaceuticals, Inc. · Gilbert, Arizona and 77 other locations · NCT07215390

• Short-term progression of geographic atrophy in people with age-related macular degeneration

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  Recruiting at 17 sites Complement Therapeutics · Mountain View, California and 18 other locations · NCT07144137

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.