Study of ALK-001 on the Progression of Stargardt Disease

ClinicalTrials.gov ID: NCT07419334

Public ClinicalTrials.gov record NCT07419334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 11:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT07419334
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Alkeus Pharmaceuticals, Inc.; Industry
Enrollment: 230 participants

Conditions and interventions

Conditions

Stargardt Disease

Interventions

ALK-001 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 8 Years to 45 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2, 2026
Primary completion: Sep 30, 2029
Completion: Nov 30, 2030
Last update posted: Aug 25, 2026

2026 – 2030

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 10

Facility	City	State	ZIP	Site status
Associated Retina Consultants	Phoenix	Arizona	85020	Recruiting
University of Colorado SOM, Sue-Anschutz-Rodgers Eye Center	Aurora	Colorado	80045	Recruiting
Vitreo Retinal Associates	Gainesville	Florida	32607	Recruiting
Foundation for Vision Research	Grand Rapids	Michigan	49546	Recruiting
Ohio State Havener Eye Institute	Columbus	Ohio	43212	Recruiting
Erie Retina Research	Erie	Pennsylvania	16505	Recruiting
Retina Foundation of the Southwest	Dallas	Texas	75231	Recruiting
Star Retina	Fort Worth	Texas	76132	Recruiting
Medical Center Ophthalmology Associates	San Antonio	Texas	78240	Recruiting
The Retina Group of Washington	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07419334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 25, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07419334 live on ClinicalTrials.gov.

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