Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADX-038, Placebo.
- Who it may be relevant to
- Registry conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug ADX-038
siRNA duplex oligonucleotide - Drug Placebo
Saline
Primary outcome measures
- Evaluate the effect of ADX-038 on the preservation of the EZ layer [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- ADARx Clinical Site — Gilbert
- ADARx Clinical Site — Phoenix
- ADARx Clinical Site — Bakersfield
- ADARx Clinical Site — Beverly Hills
- ADARx Clinical Site — Huntington Beach
- ADARx Clinical Site — Poway
- ADARx Clinical Site — Walnut Creek
- ADARx Clinical Site — Orlando
- … and 12 more centers
Australia · 7 centers
- ADARx Clinical Site — Albury
- ADARx Clinical Site — Hurstville
- ADARx Clinical Site — Parramatta
- ADARx Clinical Site — East Melbourne
- ADARx Clinical Site — Rowville
- ADARx Clinical Site — Malvern
- ADARx Clinical Site — Sydney
Canada · 5 centers
- ADARx Clinical Site — Vancouver
- ADARx Clinical Site — Vancouver
- ADARx Clinical Site — Ottawa
- ADARx Clinical Site — Toronto
- ADARx Clinical Site — Toronto
United Kingdom · 3 centers
- ADARx Clinical Site — Liverpool
- ADARx Clinical Site — London
- ADARx Clinical Site — Sunderland
Identifiers
NCT: NCT06990269 · ADX-038-202