Study of ALK-001 on the Progression of Stargardt Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alkeus Pharmaceuticals, Inc.
Study ID
NCT07419334
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Stargardt Disease

Eligibility Criteria

Sex
ALL
Age
8 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • ALK-001 — DRUG
    Daily oral administration for 24 months
  • Placebo — DRUG
    Daily oral administration for 24 months

Study Details

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)

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
  • Placebo Comparator: Placebo

Primary Outcome Measure

Annualized growth rate of retinal atrophic lesions measured by Fundus Autofluorescence [ Time Frame: Month 6 to Month 24 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsPhoenixArizona85020
Mallory Mintert
[email protected]
Benjamin Bakall, MD, PhD (PRINCIPAL_INVESTIGATOR)
Vitreo Retinal AssociatesGainesvilleFlorida32607
Hailey Ahrens
[email protected]
352-300-8412
Christine Kay, MD (PRINCIPAL_INVESTIGATOR)
Erie Retina ResearchEriePennsylvania16505
Joseph Sala
[email protected]
814-422-4852
David Almeida, MD, MBA, PhD (PRINCIPAL_INVESTIGATOR)
Retina Foundation of the SouthwestDallasTexas75231
Jessica Watson
[email protected]
214-363-3911
Karl Csaky, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Associated Retina Consultants· Phoenix, AZVitreo Retinal Associates· Gainesville, FLErie Retina Research· Erie, PARetina Foundation of the Southwest· Dallas, TX

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