ADX-038 for Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, ADX-038, for individuals with geographic atrophy (GA) due to age-related macular degeneration (AMD), a condition affecting vision. The goal is to determine if ADX-038 improves vision more effectively than a placebo (a substance with no therapeutic effect) and to assess its safety. Participants will receive either the treatment or a placebo. Individuals with GA from AMD, with lesions between 2.5 and 12.5 mm² and sufficiently clear eyes for fundus imaging, may be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude those using intravitreal complement inhibitors in the study eye.
Is there any evidence suggesting that ADX-038 is likely to be safe for humans?
Research has shown that ADX-038 is still undergoing testing to determine its safety for people. Earlier trials have studied it, but detailed safety information remains limited. Now in Phase 2 trials, the treatment has passed initial safety tests, indicating it is generally well-tolerated. However, researchers are still collecting more specific safety details to understand potential reactions. Prospective participants should always consult a healthcare professional about any concerns when considering joining a trial.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for macular degeneration, which typically involve injections of anti-VEGF drugs like Lucentis or Eylea, ADX-038 offers a novel approach. ADX-038 is unique because it targets a different pathway potentially involved in the progression of macular degeneration, which could lead to improved outcomes. Researchers are excited about ADX-038 due to its promising new mechanism of action, offering hope for enhanced efficacy and fewer side effects compared to existing therapies.
What evidence suggests that ADX-038 might be an effective treatment for macular degeneration?
Research has shown that ADX-038, which participants in this trial may receive, could help treat macular degeneration. In earlier studies, a single dose almost completely blocked the alternative pathway of the immune system for six months. This pathway contributes to the development of macular degeneration, so inhibiting it might prevent retinal damage. ADX-038 is a treatment known as siRNA, which blocks specific proteins involved in the disease. This could lead to better outcomes for patients. Although ADX-038 is still being tested in this trial, these findings are promising for its potential effectiveness.25678
Who Is on the Research Team?
Nora Dimon, MD
Principal Investigator
ADARx Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with a specific eye condition called Geographic Atrophy (GA) that's related to Age-related Macular Degeneration (AMD). Participants should have GA lesions of certain sizes and must be able to undergo fundus imaging. They need to commit to clinic visits, study procedures, and vaccinations as required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous administration of ADX-038 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADX-038
Trial Overview
The study compares the effectiveness of a new medication named ADX-038 against a placebo in treating GA due to AMD. It also looks at how the body processes the drug and its biological effects.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.
Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ADARx Pharmaceuticals, Inc.
Lead Sponsor
Citations
Phase 2 Study of ADX-038 in Participants With Geographic ...
Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, ...
ADARx Pharmaceuticals Announces Clinical Data ...
Multiple Phase 2 clinical trials have been initiated to evaluate the safety and efficacy of ADX-038 in patients with complement-mediated ...
ADARx Pharmaceuticals Announces Positive Interim Phase 1
Single subcutaneous dose of ADX-038 achieved near-complete alternative pathway suppression for 6 months, supporting potent and selective CFB ...
ADX-038 - Drug Targets, Indications, Patents
ABC aims to enhance the delivery of therapeutics, achieve deeper brain penetration and efficacy at lower doses, and ultimately improve patient outcomes while ...
ADX-038 / ADARx - Macular Degeneration
Interim Phase 1 Study Results of ADX-038: A Novel siRNA Against Complement Factor B, and Next Steps in IgAN and C3 Glomerulopathy (C3G) (KIDNEY WEEK 2025) ...
News
Multiple Phase 2 clinical trials have been initiated to evaluate the efficacy and safety of ADX-038 in patients with complement-mediated ...
ADX 038 - AdisInsight
ADX 038 is a small interfering RNA (siRNA) duplex oligonucleotide targeting complement factor B, being developed by ADARx Pharmaceuticals, for the treatment ...
ADARx Pharmaceuticals Announces Clinical Data ...
Multiple Phase 2 clinical trials have been initiated to evaluate the safety and efficacy of ADX-038 in patients with complement-mediated ...
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