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 aged 55 or older
• People who are willing and able to sign a written consent form agreeing to take part
• People who are willing and able to follow the study schedule and attend all required visits and assessments
• People who are able to apply eye drops themselves, or who have a family member or healthcare professional who can do this for them
• People whose vision in the study eye is at least 20/100 (a moderate level of vision), as confirmed at the baseline visit
• People whose glasses or contact lens prescription in the study eye falls between +3 and -6 diopters (confirm with trial site)
• People whose eyes are clear enough and whose pupils dilate well enough to allow good-quality retinal imaging, as determined by the study doctor
• People who have been diagnosed with geographic atrophy (GA) — a form of age-related damage to the back of the eye — in the study eye, where the GA is not caused by abnormal blood vessel growth, and where all of the following apply:
  • The total area of GA damage falls within a specific size range (between 1.25 and 12.0 mm²)
  • If there are multiple patches of GA, at least one patch must be at least 1.25 mm² in size
  • All GA patches must be located outside the very centre of the back of the eye (the fovea), with the central area remaining intact
  • At least part of the GA must be located within a defined distance from the centre of the fovea
  • All GA patches must be fully visible within a standard retinal imaging field, with borders a set distance from the image edges
  • All GA patches must be a set distance away from the optic disc (the point where the nerve connects to the eye)
  • The area of a related type of retinal change (called "perilesional reticular drusen" or PRD) must fall within a specific size range (confirm with trial site)

Who may not be able to join:

• People who have, or have previously had, abnormal blood vessel growth under the retina (choroidal neovascularisation), confirmed at the baseline visit
• People who have previously had laser treatment in the macular region of the eye, for any reason
• People with a history of herpes zoster (shingles)
• People who have an eye disease or condition that requires, or is likely to require, surgery during the study period
• People whose total GA area is smaller than 1.25 mm²
• People who have any GA patch within the very centre of the fovea
• People whose eye measures more than 26 mm in length (axial length)
• People who have any other eye disease or condition — besides non-neovascular AMD — that the study doctor believes could affect study results or the person's ability to follow the study schedule (for example, certain membrane conditions, macular hole, or glaucoma-related nerve damage)
• People who have had eye surgery, including cataract surgery or lens replacement, within 3 months before the first visit, or a specific type of laser eye procedure (YAG) within 2 months before the first visit, or who plan to have any such surgery during the study
• People who have used the eye medications pegcetacoplan or avacincaptad pegol within 6 months before the first visit, or who plan to use them during the study
• People who have used any prescription or over-the-counter eye medication within 1 month before the first visit, or who plan to do so during the study
• People who have worn hard (rigid) contact lenses within 1 month before the first visit, or who plan to do so during the study
• People whose non-study eye has very poor vision (below 20/800 on a standard eye chart)
• People who have a history of uveitis (inflammation inside the eye) in either eye
• People whose GA is caused by something other than non-neovascular AMD, in either eye
• People who have had an active eye infection or inflammation within 3 months before the first visit, in either eye, confirmed at the baseline visit
• People who have received an investigational (experimental) treatment for AMD within 6 months before the first visit
• People who have previously received radiation therapy to the head
• People who have a known allergy or sensitivity to the study medication or any of its ingredients
• People who have a history of cancer (malignant disease)
• People who have used the medication hydroxychloroquine within 1 month before the first visit, or who plan to use it during the study
• People who have taken part in, or plan to take part in, another clinical drug trial within 1 month before the first visit or during the study period
• People who have taken high daily doses of lutein (more than 10 mg per day) or zeaxanthin (more than 2 mg per day) within 1 month before the first visit, or who plan to do so during the study
• People who have any medical or mental health condition that, in the study doctor's opinion, could affect study results or their ability to follow the study schedule
• People whose blood test results at screening are considered by the study doctor to make them unsuitable for participation
• People who are pregnant, breastfeeding, or planning to become pregnant during the study, confirmed at the baseline visit
• People who are women of childbearing potential, or whose sexual partner is a woman of childbearing potential, and who are unwilling or unable to use an acceptable form of contraception throughout the study

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