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

First listed
Feb 19, 2026
Start date
Jun 3, 2026
Status verified
Sep 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 (14)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsPhoenixArizona85020
Mallory Mintert
[email protected]
Benjamin Bakall, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Colorado SOM, Sue-Anschutz-Rodgers Eye CenterAuroraColorado80045
Diksha Pradhan
[email protected]
303-724-9094
Marc Mathias, MD (PRINCIPAL_INVESTIGATOR)
Vitreo Retinal AssociatesGainesvilleFlorida32607
Hailey Ahrens
[email protected]
352-300-8412
Christine Kay, MD (PRINCIPAL_INVESTIGATOR)
Tufts Medical Center - New England Eye CenterBostonMassachusetts02116
Lainey Mullen
[email protected]
Helen Rahman
[email protected]
Michelle Liang, MD (PRINCIPAL_INVESTIGATOR)
Foundation for Vision ResearchGrand RapidsMichigan49546
Holly Vincent
[email protected]
616-438-9395
Liliya Sutherland, MD (PRINCIPAL_INVESTIGATOR)
Ohio State Havener Eye InstituteColumbusOhio43212
Lindsey Pyers
[email protected]
614-293-8116
Thomas Mendel, MD (PRINCIPAL_INVESTIGATOR)
Erie Retina ResearchEriePennsylvania16505
Bethany Bielak-Scott
[email protected]
814-200-9152
David Almeida, MD, MBA, PhD (PRINCIPAL_INVESTIGATOR)
Mid Atlantic RetinaPhiladelphiaPennsylvania19073
Study Coordinator
[email protected]
Sunir Garg, MD (PRINCIPAL_INVESTIGATOR)
UPMC Vision InstitutePittsburghPennsylvania15219
Study Coordinator
[email protected]
Boris Rosin, MD (PRINCIPAL_INVESTIGATOR)
Retina Foundation of the SouthwestDallasTexas75231
Jessica Watson
[email protected]
214-363-3911
Karl Csaky, MD, PhD (PRINCIPAL_INVESTIGATOR)
Star RetinaFort WorthTexas76132
Heather Gleason
[email protected]
817-378-4777
Courtney Crawford, MD, FACS (PRINCIPAL_INVESTIGATOR)
Medical Center Ophthalmology AssociatesSan AntonioTexas78240
Roxanne Casillas
[email protected]
210-697-2020
Michael Singer, MD (PRINCIPAL_INVESTIGATOR)
The Retina Group of WashingtonFairfaxVirginia22031
Katrina Arias
[email protected]
703-698-9335
Alexander Melamud, MD (PRINCIPAL_INVESTIGATOR)
Wagner Kapoor Research InstituteNorfolkVirginia23666
Sally Whitaker
[email protected]
757-271-3346
Kapil Kapoor, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Associated Retina Consultants· Phoenix, AZUniversity of Colorado SOM, Sue-Anschutz-Rodgers Eye Center· Aurora, COVitreo Retinal Associates· Gainesville, FLTufts Medical Center - New England Eye Center· Boston, MAFoundation for Vision Research· Grand Rapids, MIOhio State Havener Eye Institute· Columbus, OH

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