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A Phase 2, Randomized, Masked, Placebo-Controlled Study of ADX-038 Subcutaneous Treatment in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-04-22
240
Participants Needed
24
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ADX-038, a siRNA duplex oligonucleotide drug, in people aged 60 and older who have geographic atrophy (GA) caused by age-related macular degeneration (AMD). This Phase 2 study aims to compare ADX-038 with a placebo to assess how well it preserves the ellipsoid zone (EZ) layer in the eye over 12 months. The study also monitors safety, how the drug is processed in the body, and its biological effects. Participants will be randomly assigned to receive either ADX-038 or a saline placebo through subcutaneous injections. The study is designed as a quadruple-masked, placebo-controlled trial, ensuring that participants and researchers do not know which treatment is given. The treatment period lasts for 12 months, during which participants will attend clinic visits for dosing and assessments. Throughout the study, participants will undergo eye imaging and other evaluations to monitor the condition of their GA and the preservation of the EZ layer. Researchers will also track safety and drug activity through various tests. Participants need to complete a series of meningococcal and pneumococcal vaccinations as part of the protocol and will be followed for the full 12-month treatment period to assess outcomes and any side effects.
CONDITIONS
Brief Title
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration
- Geographic atrophy lesions between 2.5 and 12.5 mm2 at screening
- Clear ocular media with adequate pupil dilation and fixation for quality fundus imaging in the study eye
- Willing and able to comply with clinic visits and study procedures, including completing meningococcal and pneumococcal vaccinations required by the protocol
You will not qualify if you...
- Geographic atrophy caused by conditions other than age-related macular degeneration
- Active ocular disease that affects or confuses visual function
- History of retinal detachment surgery
- Any ocular condition other than geographic atrophy secondary to age-related macular degeneration
- Use of intravitreal complement inhibitors in the study eye
- Hereditary or acquired complement deficiency
- Active viral, bacterial, or fungal infection
- Liver injury indicated by abnormal liver function tests
- Currently donating blood
- History of choroidal neovascularization in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive subcutaneous injections of ADX-038 or placebo to evaluate the effect on geographic atrophy.
Regular clinic visits for treatment and assessment throughout the 12 months
Trial Site Locations
Total: 24 locations
1
ADARx Clinical Site
Gilbert, Arizona, United States, 85297
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2
ADARx Clinical Site
Phoenix, Arizona, United States, 85020
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3
ADARx Clinical Site
Beverly Hills, California, United States, 90211
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4
ADARx Clinical Site
Huntington Beach, California, United States, 93647
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5
ADARx Clinical Site
Poway, California, United States, 92064
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6
ADARx Clinical Site
Orlando, Florida, United States, 32806
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7
ADARx Clinical Site
Wildwood, Florida, United States, 34785
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8
ADARx Clinical Site
Hagerstown, Maryland, United States, 21740
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9
ADARx Clinical Site
Reno, Nevada, United States, 89502
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10
ADARx Clinical Site
Erie, Pennsylvania, United States, 16505
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11
ADARx Clinical Site
Austin, Texas, United States, 78705
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12
ADARx Clinical Site
Dallas, Texas, United States, 75231
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13
ADARx Clinical Site
McAllen, Texas, United States, 78503
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14
ADARx Clinical Site
Round Rock, Texas, United States, 78681
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15
ADARx Clinical Site
San Antonio, Texas, United States, 78340
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16
ADARx Clinical Site
The Woodlands, Texas, United States, 77384
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17
ADARx Clinical Site
St. George, Utah, United States, 84790
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18
ADARx Clinical Site
Albury, New South Wales, Australia, 2640
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19
ADARx Clinical Site
Hurstville, New South Wales, Australia, 2220
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20
ADARx Clinical Site
Parramatta, New South Wales, Australia, 2150
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21
ADARx Clinical Site
East Melbourne, Victoria, Australia, 3002
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22
ADARx Clinical Site
Rowville, Victoria, Australia, 3178
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23
ADARx Clinical Site
Ottawa, Ontario, Canada, K2B 7E9
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24
ADARx Clinical Site
Toronto, Ontario, Canada, M8X 2X3
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Research Team
N
Nali Castillo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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