Phase 3 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 active polypoidal lesions in the central area of the retina, confirmed by specific eye imaging tests, along with fluid or bleeding affecting the central part of the retina.
• People whose vision in the study eye falls within a specific range — not too strong and not too weak — as measured by a standardised eye chart test at both the screening and baseline visits.
• People whose total affected lesion area in the eye is below a certain size, as measured by a specialised eye imaging test.
• People aged 50 or older at the time of signing the consent form.
• People who, in the investigator's judgment, are able to follow the study procedures and schedule.
• Women who could become pregnant must agree to either avoid heterosexual intercourse or use contraception during the study (specific details will be outlined in the protocol).
• People who have read and signed the official consent form agreeing to take part.

Who may not be able to join:

• People who have previously received any anti-VEGF eye injection, faricimab, or any experimental drug treatment at any point before the study baseline visit.
• People who have had steroid injections in or around the eye within the 6 months before the baseline visit.
• People who have had laser treatment to the central area of the retina or a light-based therapy called PDT at any time before the baseline visit, or laser treatment to the outer areas of the retina within 3 months before baseline.
• People who have received any experimental treatment (device, drug, or traditional medicine, excluding vitamins and minerals) within 3 months before the study start.
• People who have other eye conditions in the study eye that, in the investigator's opinion, could affect how well the treatment works, affect vision, or require additional medical or surgical treatment during the first 12 months of the study.
• People who have significant scarring or tissue loss in the central part of the retina that, in the investigator's opinion, may limit how much vision can be recovered.
• People who have scarring or fibrous tissue in the central part of the retina, as seen on imaging.
• People who have bleeding covering 50% or more of the total affected lesion area, or any bleeding that covers the central point of vision.
• People who have an active infection or active inflammation inside or around the eye in either eye at the time of screening or the baseline visit.
• People who have poorly controlled glaucoma in the study eye, defined as eye pressure above 25 mmHg even while on medication, or as judged by the investigator.
• People whose eye condition appears similar to the target condition but is caused by a different underlying problem, such as abnormal blood vessels or other retinal conditions.
• People who have a history of uveitis (inflammation inside the eye) related to an immune system condition or of unknown cause, in either eye.
• People who have active inflammation or a suspected or active infection in or around either eye at the study start date.
• People who have received anti-VEGF treatment given through the body (for example, by injection into a vein) at any time before the baseline visit.
• People who have had a major illness or major surgery within 1 month before the screening visit.
• People who have had an active cancer diagnosis within the 12 months before the study start, with certain exceptions for specific low-risk cancers (confirm with trial site).
• People who are currently taking certain medications or receiving certain treatments that are listed as prohibited in the study protocol (confirm with trial site for full list).
• People who are receiving treatment for a suspected or active systemic (whole-body) infection at the study start date.
• People whose blood pressure is not well controlled, defined as systolic pressure above 180 mmHg and/or diastolic pressure above 100 mmHg while at rest on the study start date.
• People who have had a stroke or heart attack within 6 months before the study start date.
• People who have another medical condition, abnormal test result, or health history that, in the investigator's opinion, makes the study drug unsuitable for them or puts them at high risk of complications.
• People who have a history of a severe allergic or anaphylactic reaction to a biological medicine, or a known allergy to any ingredient in the faricimab injection, the eye dyes used in imaging tests, eye drops used to widen the pupil, or the anaesthetic or antibiotic preparations used during the study.
• People who are pregnant or breastfeeding, or who plan to become pregnant during the study or within 28 days after the final dose of the study drug.

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