Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT03845582 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo oral capsule
  • DRUG ALK-001 oral capsule

Study Locations (20)

Florida

  • Alkeus Site — Clearwater
  • Alkeus Site — Fort Myers
  • Alkeus Site — Gainesville
  • Alkeus Site — Tampa
  • Alkeus Site — Winter Haven

New York

  • Alkeus Site — Great Neck
  • Alkeus Site — Hauppauge

Arizona

  • Alkeus Site — Phoenix

California

  • Alkeus Site — Beverly Hills

Colorado

  • Alkeus Site — Lakewood

Illinois

  • Alkeus Site — Bloomington

Kentucky

  • Alkeus Site — Lexington

Maryland

  • Alkeus Site — Chevy Chase

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2019-05-07
Est. Completion 2024-06-30
Phase Phase 2

Sponsor

Alkeus Pharmaceuticals

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03845582

The ClinicalTrials.gov registry entry for NCT03845582 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkeus Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Geographic Atrophy appearing as the primary indexed condition, and to 2 interventions — of which Placebo oral capsule is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03845582 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03845582 about?

NCT03845582 is a clinical study titled "Phase 2/3 Study of ALK-001 in Geographic Atrophy". 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 participan...

What is the current status of trial NCT03845582?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2019-05-07. Estimated completion is 2024-06-30.

What conditions does trial NCT03845582 study?

This clinical trial studies the following conditions: Geographic Atrophy, Age Related Macular Degeneration, AMD, Atrophy, Geographic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03845582?

The interventions under investigation include: Placebo oral capsule (DRUG), ALK-001 oral capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03845582?

This trial is sponsored by Alkeus Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03845582 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial