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RecruitingPhase 3

Study of ALK-001 on the Progression of Stargardt Disease

Alkeus Pharmaceuticals, Inc. · NCT07419334

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8–45 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
230
US sites recruiting
12
Study start
June 3, 2026
Record last updated
September 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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)

Being studied: ALK-001; Placebo

Conditions: Stargardt Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male or female, 8 to 45 years of age (inclusive) on the day of screening.
  • Female participants of childbearing potential, as well as fertile male participants with female partners of childbearing potential, must be willing to comply with the protocol-defined methods of contraception from the time of consent until 90 days and 30 days, respectively, after the last dose of IMP.
  • Have a clinical diagnosis of typical autosomal recessive STGD macular dystrophy
  • Have provided a genetic report by any regional accredited organization that provides certified testing indicating the presence of disease-causing mutation.
  • Have signed and dated the informed consent forms (ICFs; or assent as appropriate) to participate.

Exclusion Criteria

  • Has taken disallowed items (supplements containing vitamin A or beta-carotene, liver-based products, or prescription oral retinoid medications) within 30 days of randomization.
  • Is lactating, pregnant, or has a positive serum or urine pregnancy test at screening or at randomization, or is planning to become pregnant during the course of study. A male participant who wishes to father a child during the course of the study.
  • Has ever participated in any gene therapy, cell therapy, or device study to treat STGD, unless documented confirmation of participation in the placebo arm with no surgery is provided. Has participated in a drug study to treat STGD within the past 6 months.
  • Has participated in any drug study to treat any other condition within 5 half-lives of the investigational drug prior to screening, unless documented confirmation of participation in the placebo arm is provided. Has participated in an investigational device study within 30 days prior to screening or longer if, in the Investigator's judgment, the device could affect study outcomes.
  • Anticipates participating in any other drug or device study within the duration of the study.

Recruiting US locations

  • Associated Retina Consultants

    Phoenix, AZ 85020

    Site contact: Mallory Mintert · hello@doctrials.com

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

    Aurora, CO 80045

    Site contact: Diksha Pradhan · 303-724-9094 · diksha.pradhan@cuanschutz.edu

  • Vitreo Retinal Associates

    Gainesville, FL 32607

    Site contact: Hailey Ahrens · 352-300-8412 · hailey@vra-pa.com

  • Foundation for Vision Research

    Grand Rapids, MI 49546

    Site contact: Holly Vincent · 616-438-9395 · holly@fvr.org

  • Ohio State Havener Eye Institute

    Columbus, OH 43212

    Site contact: Lindsey Pyers · 614-293-8116 · lindsey.pyers@osumc.edu

  • Erie Retina Research

    Erie, PA 16505

    Site contact: Bethany Bielak-Scott · 814-200-9152 · b.scott.research@pm.me

  • UPMC Vision Institute

    Pittsburgh, PA 15219

    Site contact: Study Coordinator · clinicaltrialsoph@upmc.edu

  • Retina Foundation of the Southwest

    Dallas, TX 75231

    Site contact: Jessica Watson · 214-363-3911 · jclark@retinafoundation.org

  • Star Retina

    Fort Worth, TX 76132

    Site contact: Heather Gleason · 817-378-4777 · hgleasonresearch@starretina.com

  • Medical Center Ophthalmology Associates

    San Antonio, TX 78240

    Site contact: Roxanne Casillas · 210-697-2020 · rcasillas@mcoaeyecare.com

  • The Retina Group of Washington

    Fairfax, VA 22031

    Site contact: Katrina Arias · 703-698-9335 · karias@rgw.com

  • Wagner Kapoor Research Institute

    Norfolk, VA 23666

    Site contact: Sally Whitaker · 757-271-3346 · research-staff@wagnerkapoor.com

Study contacts (from the official record)

  • For trial questions: trials@alkeuspharma.com or 877-255-7476 · 877-255-7476 · trials@alkeuspharma.com
Study of ALK-001 on the Progression of Stargardt Disease (NCT07419334) | Bored Studies