Phase 2 Macular Degeneration Trial, Recruiting

Written by an AI model from 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 are willing and able to give your agreement to take part and follow all study requirements for the whole duration of the trial.
• You are 18 years old or older.
• Your vision in the eye being studied is at a certain level: if you are the first person in your group, it must be 20/200 or worse; if you join after the first person, it must be between 20/50 and 20/200.
• You have had genetic testing confirming a change on a specific part of chromosome 11 (called 11q12-q13.1), done by an approved laboratory, showing a variant in the BEST1 gene; if your test result is more than 15 years old, you may need to be retested.
• For Best Vitelliform Macular Dystrophy (BVMD): you have one specific disease-causing change in the BEST1 gene, and your eye condition matches the advanced stage of BVMD with fluid or material under the retina.
• For Autosomal Recessive Bestrophinopathy (ARB): you have two disease-causing changes in the BEST1 gene, and your eye condition matches an ARB diagnosis.

Who may not be able to join:

• You are a woman who could become pregnant and are currently pregnant, breastfeeding, or unwilling to use effective contraception from the start of the study until one year after receiving the study treatment.
• You are a man who is unwilling to use adequate contraception from the start of the study until 180 days after receiving the study treatment.
• You have a pre-existing eye condition or other health condition that could make the planned surgery unsafe, including having a weakened immune system, being on long-term immune-suppressing medication, or being unable to take the immune-suppressing medicines required for this treatment.
• You have a medical history of another condition that could stop you from taking part or interfere with the study's tests, such as another type of bestrophinopathy (confirm with trial site).
• You have previously received any type of gene therapy.
• You have an active growth of abnormal blood vessels under the retina (choroidal neovascularization) that affects your vision or may need treatment.
• You have significant scarring under the retina (subretinal fibrosis) that is likely to prevent any improvement in vision.
• You have a membrane growing on the surface of your retina that may need surgery to remove.
• You have had a specific type of glaucoma drainage tube surgery at any time, or your glaucoma has been unstable in the past 4 years.
• You have had eye surgery within 90 days before the planned treatment, or you have ongoing eye inflammation from a previous eye surgery.
• You have taken part in another study involving an experimental drug or device within the past 90 days, or plan to do so during this study.
• You have received a vaccination within 6 weeks before the planned treatment, or plan to be vaccinated within 6 months after receiving the treatment.
• You have taken blood-thinning (anticoagulant) medication within 2 weeks before the planned treatment.
• You have active abnormal blood vessel growth in the central part of your retina, as detected by a specific eye scan (OCT-A).
• You are unable to complete vision function tests for reasons other than poor eyesight.
• You have a reason why you cannot take the steroid medication required as part of this study.
• You have any other eye, medical, or psychological condition that would prevent you from completing follow-up visits, or that the study doctor believes makes it unsafe or unsuitable for you to participate.
• You have a known allergy or sensitivity to any ingredient in the study treatment.
• You have a known infection with HIV, hepatitis B or C, or herpes simplex virus.
• You are an employee of the company running this trial, or a close relative of the study doctor or trial site staff.

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