RecruitingPhase 3NCT07419334

Study of ALK-001 on the Progression of Stargardt Disease

A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK 001) on the Progression of Stargardt Disease (STGD)


Sponsor

Alkeus Pharmaceuticals, Inc.

Enrollment

230 participants

Start Date

Jun 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates the efficacy and safety of investigational study drug ALK-001 in participants 8 to 45 years of age, inclusive, with symptoms and signs of autosomal recessive Stargardt disease (STGD)


Eligibility

Min Age: 8 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALK-001 and a drug called Placebo for people with stargardt disease. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 8 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALK-001

Daily oral administration for 24 months

DRUGPlacebo

Daily oral administration for 24 months


Locations(14)

Associated Retina Consultants

Phoenix, Arizona, United States

University of Colorado SOM, Sue-Anschutz-Rodgers Eye Center

Aurora, Colorado, United States

Vitreo Retinal Associates

Gainesville, Florida, United States

Tufts Medical Center - New England Eye Center

Boston, Massachusetts, United States

Foundation for Vision Research

Grand Rapids, Michigan, United States

Ohio State Havener Eye Institute

Columbus, Ohio, United States

Erie Retina Research

Erie, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

UPMC Vision Institute

Pittsburgh, Pennsylvania, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Star Retina

Fort Worth, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

The Retina Group of Washington

Fairfax, Virginia, United States

Wagner Kapoor Research Institute

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07419334


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