Recruiting
Phase 2

ADX-038

Sponsor:

ADARx Pharmaceuticals, Inc.

Code:

NCT06990269

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

ADX-038

Placebo

Study Details

Brief 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.

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Study ID

NCT06990269

Start date

Nov 10, 2025

Status verified date

Sep, 2026

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active - ADX-038

placebo comparator: Placebo - Saline

Interventions

ADX-038

siRNA duplex oligonucleotide

Placebo

Saline

Primary outcome measure

  • Evaluate the effect of ADX-038 on the preservation of the EZ layer [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Nali Castillo

877-232-7974info@adarx.com

Locations

ADARx Clinical Site

Recruiting

Gilbert, Arizona, United States, 85297

ADARx Clinical Site

Recruiting

Phoenix, Arizona, United States, 85020

ADARx Clinical Site

Recruiting

Bakersfield, California, United States, 93309

ADARx Clinical Site

Recruiting

Beverly Hills, California, United States, 90211

ADARx Clinical Site

Recruiting

Huntington Beach, California, United States, 93647

ADARx Clinical Site

Recruiting

Poway, California, United States, 92064

ADARx Clinical Site

Recruiting

Walnut Creek, California, United States, 94598

ADARx Clinical Site

Recruiting

Orlando, Florida, United States, 32806

ADARx Clinical Site

Recruiting

Wildwood, Florida, United States, 34785

ADARx Clinical Site

Recruiting

Hagerstown, Maryland, United States, 21740

ADARx Clinical Site

Recruiting

Reno, Nevada, United States, 89502

ADARx Clinical Site

Recruiting

Austin, Texas, United States, 78705

ADARx Clinical Site

Recruiting

Bellaire, Texas, United States, 77401

ADARx Clinical Site

Recruiting

Dallas, Texas, United States, 75231

ADARx Clinical Site

Recruiting

McAllen, Texas, United States, 78503

ADARx Clinical Site

Recruiting

Round Rock, Texas, United States, 78681

ADARx Clinical Site

Recruiting

San Antonio, Texas, United States, 78340

ADARx Clinical Site

Recruiting

The Woodlands, Texas, United States, 77384

ADARx Clinical Site

Recruiting

St. George, Utah, United States, 84790

ADARx Clinical Site

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

ADARx Clinical Site

Recruiting

Vancouver, British Columbia, Canada

ADARx Clinical Site

Recruiting

Ottawa, Ontario, Canada, K2B 7E9

ADARx Clinical Site

Recruiting

Toronto, Ontario, Canada, M3C 0G9

ADARx Clinical Site

Recruiting

Toronto, Ontario, Canada, M8X 2X3

More Information

Sponsor

ADARx Pharmaceuticals, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ADARx Pharmaceuticals, Inc. on 2026-09-03.