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:

• People who have been clinically diagnosed with a macular dystrophy that looks like Stargardt disease, confirmed by genetic testing showing specific changes in the ABCA4 gene or another gene known to cause macular dystrophy.
• People whose eyes are clear enough and whose pupils can dilate enough to allow all the required eye imaging to be done.
• People whose eye pressure (measured by a standard eye pressure test) is 21 mmHg or below at both the screening and baseline visits — including those already using eye drops to manage eye pressure.
• People whose glasses or contact lens prescription falls between +8.00 and -10.00 (very long-sighted to moderately short-sighted); people with prescriptions stronger than -10.00 may still be considered if there are no signs of short-sightedness-related damage to the back of the eye (confirm with trial site).
• People whose best corrected vision (with glasses or contacts) falls between 20/500 and 20/40, with additional specific findings on eye scans depending on how much vision has been affected.
• People who have signs of damage to a layer of cells at the back of the eye (the retinal pigment epithelium), seen on specific types of eye scans.
• People who show early or more advanced signs of cell loss at the back of the eye, as seen on a particular type of eye imaging that measures light patterns, within defined size limits.
• People who are willing and able to attend all required study visits and complete all required tests throughout the full study period.
• People who are reliably able to perform all the tests required for participation.

Who may not be able to join:

• People with a known history of serious systemic (whole-body) illnesses — such as uncontrolled hepatitis, liver failure, pancreatitis, cirrhosis, uncontrolled thyroid disease, or conditions that weaken the immune system such as HIV — that could affect eye health or interfere with study results.
• People who have an autoimmune condition being treated with medicines that suppress the immune system, including biologics.
• People with a known diagnosis of diabetes whose blood sugar control measure (HbA1c) was 7% or higher within the 3 months before screening, unless there is no history of diabetes-related eye, kidney, or other complications (confirm with trial site).
• People with any other known systemic or metabolic condition that could significantly affect eye health or make study results harder to interpret.
• People with a history or current evidence of serious heart disease, unstable chest pain, a heart attack, or heart surgery within 6 months before screening.
• People with a history or evidence of a type of irregular heart rhythm (ventricular tachyarrhythmia) that requires ongoing treatment.
• People with significant heart or blood vessel disease, including a stroke within 12 months before screening.
• People with an active or serious systemic illness or active cancer; certain skin cancers may or may not be disqualifying depending on their type, size, and location (confirm with trial site); people with a past cancer history may be considered if a treating doctor confirms no recurrence or spread for at least 5 years before screening.
• People with another confirmed or suspected genetic cause of macular or retinal disease beyond what is required for entry, which could suggest a different or additional eye condition.
• People with a history or current signs of abnormal blood vessel growth under the retina (choroidal neovascularization).
• People with macular damage caused by something other than a confirmed diagnosis of Stargardt disease or a similar macular dystrophy.
• People with uncontrolled glaucoma, including high eye pressure above 25 mmHg.
• People who have or are being treated for thyroid eye disease.
• People with more than mild diabetic damage to the retina.
• People with any other disease affecting the optic nerve.
• People with a history of inflammation inside the eye (uveitis), or current signs of eye inflammation; a single past episode with no recurrence in the last 5 years may be considered on a case-by-case basis (confirm with trial site).
• People with clouding of the cornea or lens that prevents clear viewing of the back of the eye or reliable completion of required vision tests.
• People with narrow drainage angles in the eye that make pupil dilation unsafe, where this has not already been treated with a preventative laser procedure.
• People with any other eye condition that could interfere with vision testing or eye imaging required by the study.
• People with a clinically significant membrane over the retina or significant pulling between the vitreous gel and retina; a mild finding that does not change the shape of the central retina would not be disqualifying (confirm with trial site).
• People with recurring or current bleeding inside the eye (vitreous haemorrhage); a single past episode caused by injury that has fully resolved may not be disqualifying (confirm with trial site).
• People who have no natural lens in the eye (aphakia).
• People expected to need cataract surgery during the study period.
• People with a hole in the central part of the retina (macular hole), or a history of surgery for a macular hole.
• People who have previously had certain eye surgeries, including surgery on the vitreous gel, retinal detachment repair, glaucoma surgery, glaucoma drainage device implantation, laser glaucoma treatment, or certain types of corneal transplants.
• People with any retinal lesion considered a risk for retinal detachment during the study period, unless it has been treated at least 3 months before screening.
• People who have previously had laser or photodynamic therapy treatment in the central area of the retina for any reason.
• People who have had any surgery inside the eye within 3 months before screening.
• People with a history of a metallic foreign body inside the eye.
• People who have previously received gene therapy, stem cell therapy, a surgically implanted retinal device, or any injection into the eye for any reason, if this could interfere with the study.
• People currently using any eye or systemic medication known to be harmful to the lens, retina, or optic nerve — including specific named medicines such as hydroxychloroquine, chloroquine, Elmiron, tamoxifen, chlorpromazine, thioridazine, isotretinoin, or related compounds.
• People who have had radiation therapy near the study eye.
• People who have had a major surgical procedure within 1 month before screening, or who expect to have one during the study that could interrupt participation.
• People currently taking GLP-1 receptor agonist medicines (a type of diabetes or weight management medication) who are unable or unwilling to stop taking them at least 4 weeks before screening; a past history of taking these medicines is acceptable.
• People currently taking metformin who are unable or unwilling to stop taking it at least 4 weeks before screening; a past history of taking metformin is acceptable.
• People who have taken part in an interventional clinical trial involving a vitamin A metabolism inhibitor, a vitamin A related compound, or another investigational drug within 3 months before screening; participation in an observational (non-interventional) study is allowed.
• People with a known or suspected allergy to the eye drops used to measure eye pressure or dilate the pupils.
• People with any other condition that would make participation in the study unsuitable.

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