Macular Degeneration Trial, Recruiting NCT06435000 Sponsor: Splice Bio Condition: Macular Degeneration
Back to Macular Degeneration

Macular Degeneration Trial, Recruiting

NCT06435000
Recruiting Not Applicable

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 willing and able to give written consent to participate
  • You are male or female, between 12 and 65 years old
  • You have been diagnosed with Stargardt disease (STGD1) caused by specific changes in the ABCA4 gene, confirmed by an approved genetic testing lab
  • Your Stargardt disease has shown signs of getting worse in the last 2 years, in the opinion of the doctor running the trial
  • The eye(s) being studied must have vision within a specific range — not perfect, but not below a certain level either (confirm with trial site for exact vision requirements)
  • The eye(s) being studied must show visible signs of Stargardt disease affecting the central part of the retina (the macula)
  • Special eye imaging must show a specific pattern of damage in the eye, as measured by a central imaging review centre
  • The area of damage in the eye must be fully visible in the imaging and must not be too close to the edges of the image
  • The eye(s) being studied must have clear enough eyes and pupils that can dilate (widen) enough to allow good quality retinal photographs, and you must not be allergic to the eye drops used to dilate your pupils

Who may not be able to join:

  • You are an immediate family member (such as a child or sibling) of someone who works for the company running the trial or at the trial site
  • You have another eye condition in the eye(s) being studied that could affect the trial results (note: people who have had successful cataract surgery may be eligible after 90 days)
  • You have a different inherited retinal condition caused by changes in other genes (not STGD1-related) (confirm with trial site)
  • You have had eye surgery or laser treatment to the eye within the last 90 days, or any previous laser treatment to the central part of the retina
  • You have had a major operation within the last 30 days, or are expected to have one during the study
  • You are unwilling to stop taking vitamin A or beta-carotene supplements, liver-based products, or prescription retinoid medicines during the study
  • You have taken part in another experimental treatment study within the last 90 days, or have ever had gene therapy, stem cell therapy, a retinal implant, or injections into the eye as part of a study
  • You have known serious allergies to certain eye drops or dyes used during eye examinations, or have ever had a severe allergic reaction (anaphylaxis)
  • You have a history of a "lazy eye" (amblyopia) in the eye(s) being studied
  • You have any other significant eye or health condition, or take medications, that the trial doctor believes could put you at risk or affect the study results

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 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +34 934 02 04 56

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
Not Applicable
Sponsor
Splice Bio
Registry
ClinicalTrials.gov
Start date
29 March 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇩🇪 Germany 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Document disease progression based on change from baseline in lesion size as measured by DDAF on FAF imaging

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: 20 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