Geographic Atrophy Secondary to Age-related Macular DegenerationPhase 2NCT06990269
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
A Phase 2 study testing ADX-038 in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by ADARx Pharmaceuticals, Inc. at 83 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- What is being tested?
- ADX-038
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 83 sitesin 12 countries
- Study dates
- 10 Nov 2025to 30 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
83 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
83 sites in 12 countries
United States21 sites, 20 recruiting
- Recruiting
ADARx Clinical Site
Austin, Texas, 78705
- Recruiting
ADARx Clinical Site
Bakersfield, California, 93309
- Recruiting
ADARx Clinical Site
Bellaire, Texas, 77401
- Recruiting
ADARx Clinical Site
Beverly Hills, California, 90211
- Recruiting
ADARx Clinical Site
Dallas, Texas, 75231
- Withdrawn
ADARx Clinical Site
Erie, Pennsylvania, 16505
- Recruiting
ADARx Clinical Site
Gilbert, Arizona, 85297
- Recruiting
ADARx Clinical Site
Hagerstown, Maryland, 21740
- Recruiting
ADARx Clinical Site
Huntington Beach, California, 93647
- Recruiting
ADARx Clinical Site
McAllen, Texas, 78503
- Recruiting
ADARx Clinical Site
Orlando, Florida, 32806
- Recruiting
ADARx Clinical Site
Phoenix, Arizona, 85020
- Recruiting
ADARx Clinical Site
Poway, California, 92064
- Recruiting
ADARx Clinical Site
Reno, Nevada, 89502
- Not yet recruiting
ADARx Clinical Site
Riverside, California, 92505
- Recruiting
ADARx Clinical Site
Round Rock, Texas, 78681
- Recruiting
ADARx Clinical Site
San Antonio, Texas, 78340
- Recruiting
ADARx Clinical Site
St. George, Utah, 84790
- Recruiting
ADARx Clinical Site
The Woodlands, Texas, 77384
- Recruiting
ADARx Clinical Site
Walnut Creek, California, 94598
- Recruiting
ADARx Clinical Site
Wildwood, Florida, 34785
Australia9 sites, 9 recruiting
- Recruiting
ADARx Clinical Site
Albury, New South Wales, 2640
- Recruiting
ADARx Clinical Site
East Melbourne, Victoria, 3002
- Recruiting
ADARx Clinical Site
Hurstville, New South Wales, 2220
- Recruiting
ADARx Clinical Site
Malvern, VIC 3144
- Recruiting
ADARx Clinical Site
Parramatta, New South Wales, 2150
- Recruiting
ADARx Clinical Site
Rowville, Victoria, 3178
- Recruiting
ADARx Clinical Site
Sutherland, New South Wales, 2232
- Recruiting
ADARx Clinical Site
Sydney, New South Wales, 2000
- Recruiting
ADARx Clinical Site
Sydney, NWS 2000
Canada8 sites, 8 recruiting
- Not yet recruiting
ADARx Clinical Site
Edmonton, Alberta, T5H 0X5
- Not yet recruiting
ADARx Clinical Site
London, Ontario, N6A4V2
- Not yet recruiting
ADARx Clinical Site
Ottawa, Ontario, K1H 8L6
- Recruiting
ADARx Clinical Site
Ottawa, Ontario, K2B 7E9
- Recruiting
ADARx Clinical Site
Toronto, Ontario, M3C 0G9
- Recruiting
ADARx Clinical Site
Toronto, Ontario, M8X 2X3
- Recruiting
ADARx Clinical Site
Vancouver, British Columbia, V5Z 1M9
- Recruiting
ADARx Clinical Site
Vancouver, British Columbia
Germany8 sites, 8 recruiting
- Not yet recruiting
ADARx Clinical Site
Bonn, North Rhine-Westphalia, 53127
- Not yet recruiting
ADARx Clinical Site
Cologne, 50937
- Not yet recruiting
ADARx Clinical Site
Giessen, 35392
- Not yet recruiting
ADARx Clinical Site
Mainz, 55122
- Not yet recruiting
ADARx Clinical Site
München, 80336
- Not yet recruiting
ADARx Clinical Site
Münster, 48149
- Not yet recruiting
ADARx Clinical Site
Sulzbach, Saarland, 66280
- Not yet recruiting
ADARx Clinical Site
Tübingen, 72076
Italy7 sites, 7 recruiting
- Not yet recruiting
ADARx Clinical Site
Milan, MI, 20132
- Not yet recruiting
ADARx Clinical Site
Milan, 20121
- Not yet recruiting
ADARx Clinical Site
Milan, 20122
- Not yet recruiting
ADARx Clinical Site
Milan, 20142
- Not yet recruiting
ADARx Clinical Site
Novara, 28100
- Not yet recruiting
ADARx Clinical Site
Padova, 35128
- Not yet recruiting
ADARx Clinical Site
Roma, RM, 00168
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
ADARx Clinical Site
Dorchester, Dorset, DT1 2JY
- Recruiting
ADARx Clinical Site
Liverpool, BC, L7 8XP
- Recruiting
ADARx Clinical Site
London, NW10 7NS
- Recruiting
ADARx Clinical Site
London, SW17 0QT
- Recruiting
ADARx Clinical Site
Sunderland, SR1 3AE
- Recruiting
ADARx Clinical Site
Wolverhampton, West Midlands, WV10 0QP
Hungary5 sites, 5 recruiting
- Not yet recruiting
ADARx Clinical Site
Budapest, 1085
- Not yet recruiting
ADARx Clinical Site
Budapest, 1106
- Not yet recruiting
ADARx Clinical Site
Budapest, 1133
- Not yet recruiting
ADARx Clinical Site
Debrecen, 4032
- Not yet recruiting
ADARx Clinical Site
Pécs, Baranya, 7621
Spain5 sites, 5 recruiting
- Not yet recruiting
ADARx Clinical Site
Barcelona, 08022
- Not yet recruiting
ADARx Clinical Site
Barcelona, 08035
- Not yet recruiting
ADARx Clinical Site
Barcelona, 08908
- Not yet recruiting
ADARx Clinical Site
Madrid, 28040
- Not yet recruiting
ADARx Clinical Site
Valencia, 46004
Austria4 sites, 4 recruiting
- Not yet recruiting
ADARx Clinical Site
Graz, Styria, 8036
- Not yet recruiting
ADARx Clinical Site
Innsbruck, Tyrol, 6020
- Not yet recruiting
ADARx Clinical Site
Vienna, 1090
- Not yet recruiting
ADARx Clinical Site
Vienna, 1140
Portugal4 sites, 4 recruiting
- Not yet recruiting
ADARx Clinical Site
Coimbra, 3000-548
- Not yet recruiting
ADARx Clinical Site
Coimbra, 3004-561
- Not yet recruiting
ADARx Clinical Site
Coimbra, 3030-163
- Not yet recruiting
ADARx Clinical Site
Porto, 4200-319
Czechia3 sites, 3 recruiting
- Not yet recruiting
ADARx Clinical Site
Prague, 100 34
- Not yet recruiting
ADARx Clinical Site
Prague, 140 00
- Not yet recruiting
ADARx Clinical Site
Praha Klanovice, 12808
Switzerland3 sites, 3 recruiting
- Recruiting
ADARx Clinical Site
Basel, 4031
- Recruiting
ADARx Clinical Site
Bern, 3010
- Not yet recruiting
ADARx Clinical Site
Olten, Canton of Solothurn, 4600
About this study
Official title: 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 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.
- Being tested
- ADX-038, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-038Drug
Also called siRNA
siRNA duplex oligonucleotide
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Active - ADX-038 | Experimental | Not described Receives: Drug: ADX-038 |
| Placebo - Saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of ADX-038 on the preservation of the EZ layer
Rate of change in the area of total EZ loss in the study eye from baseline to Month 12
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start10 Nov 2025
- Primary completion28 Feb 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Secondary to Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Masked, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADARx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wendy Murahashi, Study director, ADARx Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990269
- Sponsor's protocol ID
- ADX-038-202
- Status last verified
- Sep 2026
- First submitted
- 22 May 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06990269
- Acronym / sponsor ID
- ADX-038-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- ADARx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Masked, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Active - ADX-038 | Experimental | Drug: ADX-038 |
| Placebo - Saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-038Also: siRNAsiRNA duplex oligonucleotide | Drug | Active - ADX-038 |
| PlaceboSaline | Drug | Placebo - Saline |
Primary outcome
Evaluate the effect of ADX-038 on the preservation of the EZ layer
Time frame: 12 months
Rate of change in the area of total EZ loss in the study eye from baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Murahashi study director
ADARx Pharmaceuticals, Inc.
83 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-038 in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by ADARx Pharmaceuticals, Inc. at 83 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Australia, Canada, Germany, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nali Castillo (877-232-7974, info@adarx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of ADX-038 on the preservation of the EZ layer (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.