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New treatment option for Geographic Atrophy Secondary to Age-related Macular Degeneration
Official title Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
ClinicalTrials.gov ID: NCT06990269
What this study is testing
What is ADX-038?
ADX-038 is an investigational medicine, being studied as a potential treatment for geographic atrophy secondary to age-related macular degeneration.
Also referred to as siRNA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
- Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Huntington Beach, California, United States
- Poway, California, United States
- Orlando, Florida, United States
- Wildwood, Florida, United States
- Hagerstown, Maryland, United States
- Reno, Nevada, United States
- Erie, Pennsylvania, United States
- Austin, Texas, United States
- Bellaire, Texas, United States
- Dallas, Texas, United States
- McAllen, Texas, United States
- Round Rock, Texas, United States
- San Antonio, Texas, United States
- The Woodlands, Texas, United States
- St. George, Utah, United States
- Albury, New South Wales, Australia
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Phoenix, Arizona, United States; Bakersfield, California, United States; Beverly Hills, California, United States; Huntington Beach, California, United States; Poway, California, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.