Phase 4 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 willing to take part voluntarily and are able to sign a written consent form
• Adults aged 50 years or older at the time of joining the study
• People who, in the opinion of the study doctor, are able to follow the study requirements
• People whose vision in the study eye meets a minimum level on a standard eye chart test at the screening visit (a score of 24 letters or more on the ETDRS chart)
• People who have been diagnosed by the study doctor with active wet age-related macular degeneration (wet AMD), where the eye is clear enough to allow good quality retinal images to be taken
• People who have never previously received any treatment for their wet AMD (treatment naïve)
• For people with a specific type of wet AMD called polypoidal choroidal vasculopathy (PCV): those who have active polypoidal lesions in the central part of the retina confirmed by a specific eye imaging test (ICGA), along with signs of bleeding or fluid under the retina
• For people with PCV: those whose total affected lesion area, as measured by ICGA, is below a certain size (less than 5400 μm in its longest dimension)

Who may not be able to join:

• People who have had a serious illness or major surgery within 1 month before the screening visit
• People who have any condition that, in the study doctor's opinion, makes the study drug (faricimab) unsuitable for them, could affect study results, or puts them at high risk of complications
• People with a history of active cancer in the 12 months before screening, except for certain treated, low-risk cancers such as early-stage cervical cancer, common skin cancers (non-melanoma), or low-grade stable prostate cancer (confirm with trial site)
• People with very high blood pressure that is not under control (above 180/100 mmHg while resting at the time of the baseline visit)
• People with immune system conditions that may affect certain inflammatory markers measured in the fluid at the front of the eye
• People with a history of severe allergic reactions to biological medicines, or known allergies to faricimab or any of the dyes, eye drops, or other products used during the study
• People who are currently being treated for a suspected or active infection throughout the body at the time of screening
• People who have taken certain medications known to be harmful to the lens, retina, or optic nerve within 6 months before screening, or who are expected to need such medications during the study
• People who have received medicines that affect the immune system or suppress it within 6 months before screening
• People who have taken part in another clinical trial involving an experimental drug or device within 3 months before screening, or who are currently in another such trial
• Women who are pregnant or breastfeeding
• Women who could become pregnant and are planning a pregnancy during the study or within 3 months after the last dose, or who are unwilling to use highly effective contraception throughout the study and for 3 months after the last dose
• People who have any eye condition in the study eye that could interfere with vision testing, safety checks, or retinal imaging (for example, a severe cataract)
• People who have any current eye disease in the study eye that, in the study doctor's opinion, would make the eye injection procedure riskier than usual, or could interfere with the treatment or assessments
• People whose study eye has significant scarring or tissue loss covering 50% or more of the affected area and/or the central part of the retina (the fovea)
• People who have a tear in a specific layer of the retina (the retinal pigment epithelium) in the central area of the study eye
• People with very high short-sightedness (greater than 6 diopters) in the study eye, or whose short-sightedness before laser or cataract eye surgery exceeded this level
• People who have bleeding inside the eye (vitreous hemorrhage) in the study eye at the time of screening or the baseline visit
• People with a history of other diseases affecting the central retina in the study eye that are unrelated to AMD but could cause vision loss or fluid build-up in the retina
• People with a history of diabetic eye disease, including proliferative diabetic retinopathy or diabetic macular swelling, or other retinal blood vessel diseases in the study eye (apart from AMD)
• People who have any current eye condition in the study eye that, in the study doctor's opinion, is likely to need medical or surgical treatment during the study period
• People who have previously had surgery inside the study eye, including operations such as vitrectomy, glaucoma surgery, corneal transplant, retinal detachment repair, or other eye surgeries
• People who have previously received or are currently receiving any treatment for abnormal blood vessel growth under the retina (macular neovascularization) in the study eye, including injections into the eye, laser treatments, or other eye procedures
• People who have glaucoma in the study eye with eye pressure that remains at 25 mmHg or above despite using eye pressure-lowering medication
• People who have active inflammation in either eye, or a suspected or active infection in or around either eye at the time of screening

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