Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorADARx Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ADX-038
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov