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 were first diagnosed with a condition called neovascular age-related macular degeneration (nAMD) — a type of wet macular degeneration — within the last 24 months before the screening visit
• People who have already received at least 3 eye injections (called anti-VEGF injections) for nAMD as part of their regular care, within the last 6 months before screening
• People whose vision or eye condition showed some improvement or response to those previous eye injections since their diagnosis
• People for whom historical vision test records are available from the time of their nAMD diagnosis and before their first eye injection
• People for whom historical eye scan (OCT) images are available from the time of their nAMD diagnosis and before their first eye injection
• People whose vision in the study eye meets a minimum level of clarity, measured at 34 letters or better on a specific eye chart test (called ETDRS) at both the screening and enrolment visits

Who may not be able to join:

• People who have had certain eye surgeries on the study eye, including surgery inside the eye (vitrectomy), surgery under the macula, or other surgical treatments for macular degeneration
• People who have previously had a steroid injection inside the study eye
• People who have had a device implanted inside the study eye
• People who have had bleeding inside the eye (vitreous hemorrhage) in the study eye
• People who have had a certain type of retinal detachment (rhegmatogenous) in the study eye
• People who have had glaucoma surgery of any kind in the study eye
• People who have had a corneal transplant in the study eye
• People who have had a severe allergic or anaphylactic reaction to a biologic medicine, or who are known to be allergic to ranibizumab (the injection used in this trial), fluorescein dye, eye-dilating drops, or anaesthetic or antibiotic preparations used during the study (either eye)
• People who have previously taken part in a clinical trial using an experimental treatment for nAMD (either eye)
• People who have previously been treated with a medicine called brolucizumab or with gene therapy for nAMD (either eye)
• People whose study eye has bleeding under the retina that affects the central part of the macula (fovea)
• People whose study eye has scarring or tissue loss (atrophy) directly under the central part of the macula
• People whose abnormal blood vessel growth (CNV) is caused by something other than age-related macular degeneration, such as eye infection history, injury, or extreme short-sightedness (either eye)
• People whose eye condition appears to be mimicking CNV but may have a different cause (either eye) (confirm with trial site)
• People whose study eye has a tear in a specific layer of the retina near or under the central macula
• People whose study eye has any other eye condition that might need surgery during the trial or could affect the results
• People with active inflammation inside the study eye
• People with untreated retinal tears in the study eye, or tears treated within the last 3 months before enrolment
• People whose study eye is missing its natural lens and lens capsule (aphakia or absent posterior capsule)
• People with uncontrolled pressure inside the study eye or uncontrolled glaucoma
• People with a history or current presence of certain eyelid or eye surface conditions in the study eye, including severe eyelid inflammation, recurring eyelid cysts or styes, severe dry eye, or severe allergic eye disease
• People with inward-growing eyelashes (trichiasis) in the study eye
• People with reduced sensation in the surface of the study eye (corneal neuropathy)
• People who cannot fully close their eyelid or blink completely in the study eye
• People with active or past facial nerve weakness or paralysis affecting the study eye
• People whose non-study eye has very poor vision (hand motion or worse) or who have only one eye
• People with active or past uveitis (internal eye inflammation) in either eye
• People with active or past certain eye infections or inflammations (keratitis, scleritis, endophthalmitis, or chronic blepharitis) in either eye
• People with suspected or active infectious eye conditions in either eye
• People with active or past floppy eyelid syndrome in either eye
• People with active thyroid eye disease in either eye
• People with uncontrolled high blood pressure
• People with active or past autoimmune diseases
• People who have had a stroke within the last 3 months
• People who have been newly diagnosed with or had a worsening of atrial fibrillation (an irregular heart rhythm) within the last 3 months
• People who have had a heart attack within the last 3 months
• People with a confirmed active infection affecting the whole body
• People with other diseases, conditions, or abnormal test results that could make the use of ranibizumab or the implant unsafe, or could affect the trial results
• People currently using anti-VEGF medicines taken by mouth or through the whole body (systemic)
• People who regularly take oral steroid (corticosteroid) tablets
• People with an active cancer diagnosis within the last 12 months before enrolment, with some exceptions including certain treated skin cancers, treated cervical changes, and prostate cancer (confirm specific exceptions with trial site)

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