Phase 2 Macular Degeneration Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be willing and able to sign a consent form agreeing to take part (younger participants will also need to give their own agreement).
• In Part A of the trial, you must be between 18 and 65 years old; in Part B, you must be between 12 and 65 years old (people over 65 may still be considered after special approval).
• You must be able to understand and follow the study's procedures and instructions.
• You must have been diagnosed with Stargardt disease type 1 (STGD1) caused by changes in both copies of the ABCA4 gene, confirmed by an accredited genetic testing laboratory.
• You must have clinical signs that are consistent with Stargardt disease type 1.
• If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the screening process and before receiving treatment.
• If you are a woman who could become pregnant, or a man whose female partner could become pregnant, you must agree to either abstain from sex or use an approved form of contraception for 3 months from the start of treatment.
• The eye being studied must have clear enough media (the inside of the eye) and your pupil must be able to dilate fully to allow good quality eye imaging, with no allergy to dilating eye drops.
• Your vision must meet specific requirements as measured by a standard eye chart used in the study (confirm with trial site).
• The size of the affected area in your eye must meet specific measurements as assessed by the study's reading center (confirm with trial site).
• There must be evidence that your disease has been getting worse over time, as confirmed by the study's medical team.

Who may not be able to join:

• You have had eye surgery (including cataract surgery) or laser treatment in the study eye within the past 90 days, or you have any such procedures planned during the trial.
• You have had any major surgery anywhere on your body within the past 30 days, or you have major surgery planned during the trial.
• You have been found to have changes in other inherited eye disease genes (besides ABCA4) that could cause a separate inherited eye condition (confirm with trial site).
• You have a history of a "lazy eye" (amblyopia) in the eye being studied.
• You are unwilling to stop taking vitamin A or beta-carotene supplements, liver-based products, or prescription retinoid tablets for the duration of the study (note: skin creams containing vitamin A or retinoids are allowed).
• You have previously received gene therapy, stem cell therapy, a retinal implant, or any injections into or around your eye for an eye condition.
• You have taken part in another clinical trial or received an experimental treatment within the past 90 days (or longer, depending on the treatment).
• You have a known serious allergy to fluorescein dye, eye-dilating drops, topical eye anaesthetic, steroid medication, or any ingredient in the study treatment (SB-007).
• You have another significant eye condition or other health condition that the study doctors believe could put you at risk, affect the study results, or prevent you from fully participating.
• You are a close family member (such as a child or sibling) of someone who works for the company running the trial or at the trial site.

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