Phase 3 Macular Degeneration Trial, Recruiting NCT07419334 Sponsor: Alkeus Pharmaceuticals, Inc. Condition: Macular Degeneration
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Phase 3 Macular Degeneration Trial, Recruiting

NCT07419334
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 8 and 45 years old (inclusive) at the time of screening
  • If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must be willing to use approved contraception methods from consent until a set period after the last dose (confirm with trial site for exact timeframes)
  • You have been clinically diagnosed with the typical inherited (autosomal recessive) form of Stargardt macular dystrophy
  • You have a genetic test report from an accredited organisation confirming you carry the disease-causing gene mutation
  • You are willing to sign and date the required consent forms (or assent forms, if appropriate for your age)

Who may not be able to join:

  • You have taken vitamin A supplements, beta-carotene supplements, liver-based products, or prescription retinoid medications within the 30 days before joining the trial
  • You are currently breastfeeding, pregnant, have a positive pregnancy test at screening or at the start of the trial, or plan to become pregnant during the study — or you are a man who plans to father a child during the study
  • You have previously taken part in a gene therapy, cell therapy, or device study to treat Stargardt disease (unless you can confirm you were in a placebo group with no surgery), or you have taken part in a drug study to treat Stargardt disease within the past 6 months
  • You have taken part in a study of any other investigational drug or device recently (the exact timeframe depends on the drug or device involved — confirm with trial site)
  • You plan to join any other drug or device study while this trial is ongoing

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 877-255-7476

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Alkeus Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 October 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Annualized growth rate of retinal atrophic lesions measured by Fundus Autofluorescence

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov