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:

• People who are 55 years of age or older.
• People who have been diagnosed with dry age-related macular degeneration (AMD), meaning at least one medium or large deposit (called a drusen) has been found in the central part of the eye, and a condition called geographic atrophy (an area of cell loss at the back of the eye) is present in at least one eye.
• People who are able to understand and sign the study's consent form.
• People of childbearing potential must have a negative pregnancy test at the screening visit and be willing to be tested again before the transplant procedure.
• People who could become pregnant, or whose partner could become pregnant, must be using an effective method of birth control (such as hormonal contraception, an intrauterine device, barrier methods with spermicide, or surgical sterilisation), or have had a hysterectomy or vasectomy, or be completely abstinent, through the first 12 months of the study.
• People who are healthy enough to safely receive anaesthesia for surgery and to attend all required study visits and procedures.
• The eye being treated (called the "study eye") must have one or more areas of geographic atrophy totalling at least one disc area in size, located near the centre of the eye's vision, as confirmed by a specific type of eye imaging.
• For the first group of participants, the study eye must have a certain level of reduced vision (roughly equivalent to 20/100 or worse, down to counting fingers), and the other eye must have vision no more than five letters worse than the study eye on a standardised vision test.
• For the second group of participants, the study eye must have a certain level of reduced vision (roughly equivalent to 20/80 or worse, down to counting fingers), and the other eye must have vision no more than five letters worse than the study eye on a standardised vision test.
• The vision loss in the study eye must be judged by the investigator to be caused mainly by dry AMD.
• The study eye must have clear enough media (the internal structures of the eye) and a pupil that can dilate sufficiently to allow safe surgery and eye photography.
• The study eye must already have had its natural lens removed (either replaced with an artificial lens, or the lens is absent).

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an investigational medication.
• People with certain health conditions that would make it significantly riskier to use corticosteroids or immune-suppressing medications — including poorly controlled diabetes (HbA1c above 7.5), significant liver disease, severely reduced kidney function lasting three months or more, or an active infection with HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C.
• People with a cancer diagnosis that is expected to affect survival within two years.
• People who are currently pregnant, breastfeeding, or planning to become pregnant within the first 12 months of the study.
• People with a family history of an inherited retinal disease (other than AMD) that the investigator believes may be contributing to the eye condition.
• People who are currently taking, or have taken within the past year, medications known to be harmful to the retina, optic nerve, or lens (such as chloroquine, hydroxychloroquine, or ethambutol).
• People taking blood-thinning medications that cannot be safely stopped for an extended period, as determined by the study investigators and the prescribing doctor.
• People who are unable or unwilling to consent to the use of their medical records and tissue samples for current and future research.
• People whose study eye has, or has previously had, abnormal blood vessel growth under or in the retina (neovascularisation).
• People whose study eye has a significant fluid- or blood-filled blister under the retina (pigment epithelial detachment), as judged by the investigator.
• People whose study eye has previously been treated with photodynamic therapy, macular laser treatment, or injections of anti-VEGF drugs or corticosteroids into the eye (with the exception of medications used during prior cataract surgery). Anti-complement injections into the study eye within the 12 weeks before enrolment are also exclusionary; those given more than 12 weeks prior are not.
• People whose study eye is longer than 25.0 mm (a measurement of the physical length of the eyeball).
• People whose study eye has had surgery within the past 12 weeks, or a laser capsulotomy procedure within the past four weeks.
• People whose study eye has glaucoma, significantly elevated eye pressure, or a history of eye pressure rising in response to steroids; or whose other eye has glaucoma or high eye pressure that the investigator believes significantly increases the risk for the study eye.
• People whose study eye has another condition that the investigator judges to materially increase the risks of surgery or could significantly affect vision over the next two years — such as chronic eye inflammation, diabetic retinal disease, certain corneal or eye surface conditions, optic nerve disease, untreated retinal detachment, macular swelling, or severe short-sightedness, among others.

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