Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

Last updated: February 27, 2026
Sponsor: ADARx Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Geographic Atrophy

Macular Degeneration

Treatment

Placebo

ADX-038

Clinical Study ID

NCT06990269
ADX-038-202
  • Ages > 60
  • All Genders

Study Summary

Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.

Eligibility Criteria

Inclusion

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 permitquality 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 andpneumococcal vaccination required per protocol

Exclusion

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

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 10, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • ADARx Clinical Site

    Albury 2178174, New South Wales 2155400 2640
    Australia

    Active - Recruiting

  • ADARx Clinical Site

    Parramatta 7281840, New South Wales 2155400 2150
    Australia

    Active - Recruiting

  • ADARx Clinical Site

    Rowville 2150894, Victoria 2145234 3178
    Australia

    Active - Recruiting

  • ADARx Clinical Site

    Ottawa 6094817, Ontario 6093943 K2B 7E9
    Canada

    Active - Recruiting

  • ADARx Clinical Site

    Toronto 6167865, Ontario 6093943 M8X 2X3
    Canada

    Active - Recruiting

  • ADARx Clinical Site

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Active - Recruiting

  • ADARx Clinical Site

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Active - Recruiting

  • ADARx Clinical Site

    Beverly Hills 5328041, California 5332921 90211
    United States

    Active - Recruiting

  • ADARx Clinical Site

    Huntington Beach 5358705, California 5332921 93647
    United States

    Site Not Available

  • ADARx Clinical Site

    Poway 5384690, California 5332921 92064
    United States

    Site Not Available

  • ADARx Clinical Site

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • ADARx Clinical Site

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Active - Recruiting

  • ADARx Clinical Site

    Erie 5188843, Pennsylvania 6254927 16505
    United States

    Active - Recruiting

  • ADARx Clinical Site

    McAllen 4709796, Texas 4736286 78503
    United States

    Active - Recruiting

  • ADARx Clinical Site

    Round Rock 4724129, Texas 4736286 78681
    United States

    Active - Recruiting

  • ADARx Clinical Site

    San Antonio 4726206, Texas 4736286 78340
    United States

    Active - Recruiting

  • ADARx Clinical Site

    The Woodlands 4736476, Texas 4736286 77384
    United States

    Site Not Available

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