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Phase 2/3 Study of ALK-001 in Geographic Atrophy

NCT03845582 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-03

Study results available
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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.

Conditions

Interventions

DRUG

ALK-001 oral capsule

Daily administration for 24 months

DRUG

Placebo oral capsule

Daily administration for 24 months

Sponsors & Collaborators

  • Alkeus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2023-07-25
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03845582 on ClinicalTrials.gov