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:

• People aged 55 to 85 years old at the time of joining the trial.
• People who are able to understand and sign the trial's consent form.
• People who have a specific type of eye condition called geographic atrophy (GA) — an area of damage to the back of the eye — in at least one eye, where that damaged area falls within a certain size range (not too small, not too large). This can be in the centre of the eye or off-centre.
• People whose affected eye has a stable focal point for vision (either central or just off-centre) and whose eye is clear enough for good quality photographs to be taken.
• People whose vision in the affected eye falls within a certain range — roughly between normal vision and moderately reduced vision (20/20 to 20/200).
• People who have a brain MRI scan with no concerning findings before starting the study medication called Tecfidera (this applies only to participants assigned to the Tecfidera group).
• Male participants whose female partners are able to become pregnant must use condoms during the study and for four months after the last dose of the experimental treatment.
• People with no personal history of heart disease, no family history of sudden death, and a normal heart rhythm reading on an ECG (a specific measurement called QTc must be below 480ms).
• People who are enrolled in a social security scheme (confirm with trial site, as this may reflect a French healthcare requirement).

Who may not be able to join:

• People who have taken part in another interventional clinical trial within the past 3 months.
• People who are unable to follow the study procedures or attend follow-up visits.
• People who have another eye disease (besides GA) in either eye that could affect the study results — for example, glaucoma, significant diabetic eye disease, inflammation of the eye, or certain other conditions affecting the retina.
• People who have a history of a wet (neovascular) form of age-related macular degeneration (AMD).
• People who have received certain treatments for wet AMD in the study eye within the last four months, such as laser treatment, a specific light-based therapy, or injections into the eye. (Vitamin supplements for AMD do not count as an exclusion.)
• People who have had surgery to remove the gel inside the eye (vitrectomy) in the study eye.
• People who are expected to need eye surgery during the trial period.
• People who have had their eye lens removed in the last three months, or a specific type of laser eye procedure (YAG laser) within the last month.
• People who are currently receiving chemotherapy.
• People who have been taking immune-suppressing medications (by eye drops or by mouth/injection) for more than 3 months, or whose immune system is already suppressed.
• People taking any eye or body-wide medications known to be harmful to the lens, retina, or optic nerve.
• People with a history of cancer that could affect their survival over the 2-year study period.
• People with a history of a specific eye infection caused by the herpes simplex virus.
• People who have a known allergy or medical reason they cannot take the study drug Dimethyl Fumarate (Tecfidera) or related ingredients.
• People with severe active disease of the digestive system.
• People who are unable to have an MRI scan using a contrast dye called gadolinium — for example, due to a pacemaker, certain heart valves, cochlear implants, or other metal implants that are not MRI-compatible.
• People who have other reasons they cannot receive gadolinium dye, including pregnancy, a previous allergic reaction to it, or severe kidney disease.
• People who have a medical reason they cannot take aspirin.
• People whose blood, urine, or chemistry test results are significantly abnormal at screening (more than 3 times outside the normal range, or considered clinically significant by the investigator).
• People who have a low white blood cell count (specifically low lymphocytes) at the time of joining.
• People with severe damage to a major organ, including severe liver or kidney disease.
• People who have previously received an organ transplant.
• People who have taken certain medications within the 3 months before joining, including other fumaric acid-related drugs, immune-modifying treatments, certain steroids used long-term, cancer-related drugs, or live vaccines.
• People who have taken certain medications within the 3 months before joining that can harm the kidneys, including some antibiotics (aminoglycosides), certain water tablets (diuretics), some anti-inflammatory drugs, or lithium.
• People with any other condition that, in the investigator's judgement, would make participation unsafe or unsuitable — such as poorly controlled blood pressure or blood sugar.
• People with a history of cancer (other than a common type of skin cancer) diagnosed within the last 5 years, where the cancer could be made worse by immune suppression. (An oncology consultation would be needed before any such person could be considered.)
• People with active inflammation or infection in or around either eye.
• People with active or inactive toxoplasmosis (a parasitic infection) affecting either eye.
• People with an active or latent (hidden/inactive) tuberculosis infection.
• Women who are able to become pregnant — meaning those who have not gone through menopause (defined as 12 months without a period, with a hormone test if needed) or have not had a surgical procedure making pregnancy impossible.
• People who are under a legal guardianship or curatorship arrangement (confirm with trial site, as this may reflect a French legal requirement).

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