Phase 3
Completed N=198
Phase 2/3 Study of ALK-001 in Geographic Atrophy
Geographic Atrophy · Age-Related Macular Degeneration · AMD · Atrophy, Geographic
Source: ClinicalTrials.gov NCT03845582 ↗
Enrolled (actual)
198
Serious AEs
20.2%
Results posted
Oct 2025
Primary outcomePrimary: Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF) — 1.62; 1.87 mm2/year
◆ Published Evidence
Established
46citations · ~15 / year
Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration.
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.
Linked Publications
-
Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.