Phase 3
N=198
Phase 2/3 Study of ALK-001 in Geographic Atrophy
Geographic Atrophy · Age Related Macular Degeneration · AMD · Atrophy, Geographic
Bottom Line
View on ClinicalTrials.gov: NCT03845582 ↗Enrolled (actual)
198
Serious AEs
20.2%
Results posted
Oct 2025
Primary outcome: Primary: Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF) — 1.62; 1.87 mm2/year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALK-001 oral capsule (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Alkeus Pharmaceuticals, Inc.
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF) |
1.62; 1.87 | — |
| SECONDARY Number of Participants With Adverse Events |
97; 52 | — |
| SECONDARY Changes in Visual Acuity |
-3.896; -8.298; -6.862; -10.161 | — |
Summary
This is a double-masked, multicenter, randomized, placebo-controlled clinical trial, evaluating the efficacy and safety of ALK-001 in participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).
Up to 200 participants will receive ALK-001 while up to 100 participants will receive a placebo.
Eligibility Criteria
Major Inclusion Criteria:
- At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD)
Major Exclusion Criteria:
- Medical condition, which may interfere with the progression of GA, prevent performance of study procedures, compliance with protocol, or continuous participation in the study
Data sourced from ClinicalTrials.gov (NCT03845582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.