CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
ALK-001 oral capsule +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03845582
NCT03845582Phase 3Completed

A Phase 2/3 Multicenter, Randomized, Double-masked, Parallel-group, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, Tolerability, and Efficacy of ALK-001 in Geographic Atrophy Secondary to Age-related Macular Degeneration

Alkeus Pharmaceuticals, Inc.·interventional·Posted Feb 19, 2019·Updated Nov 3, 2025

In Brief

A Phase 3 clinical trial evaluating ALK-001 oral capsule and Placebo oral capsule for Geographic Atrophy and 3 related conditions. Completed, enrolled 200 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 19, 2019
Enrollment StartMay 7, 2019
Primary CompletionJul 25, 2023
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.4 years ago

Interventions

ALK-001 oral capsuledrug

Daily administration for 24 months

Placebo oral capsuledrug

Daily administration for 24 months