Geographic Atrophy Secondary to Age-related Macular Degeneration
Conditions
Brief 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.
Interventions
DRUGADX-038
siRNA duplex oligonucleotide
DRUGPlacebo
Saline
Sponsors
ADARx Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, Masked, Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of ADX-038 on the preservation of the EZ layer | 12 months | Rate of change in the area of total EZ loss in the study eye from baseline to Month 12 |
Countries
Australia, Austria, Canada, Czechia, Germany, Hungary, Italy, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTNali Castillo
STUDY_DIRECTORWendy Murahashi
ADARx Pharmaceuticals, Inc.
Outcome results
None listed