Phase 3 Macular Degeneration Trial, Recruiting

Written by an AI model from the 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 type of wet age-related macular degeneration (wet AMD) within the 9 months before their screening appointment
• People who have already received at least three injections into the eye (called anti-VEGF injections) as standard treatment for wet AMD in the 6 months before their screening appointment
• People whose vision showed improvement or stabilisation in response to those prior injections
• People for whom historical vision test records are available from before their first injection up to the screening visit
• People whose vision in the study eye measures at a certain level or better on a standard eye chart test (34 letters or better on the ETDRS chart, roughly equivalent to 20/200 on a Snellen chart)
• People with any subtype of wet AMD lesion
• People whose eye is clear enough, and whose pupil can be dilated enough, for detailed eye imaging tests to be carried out and assessed by a specialist reading centre

Who may not be able to join:

Related to the study eye — previous treatments or surgeries:

• People who have had certain eye surgeries for AMD, such as vitrectomy or surgery under the retina
• People who have previously been treated with a light-activated therapy called Visudyne, external radiation, or a heat-based treatment called transpupillary thermotherapy
• People who have previously had steroid injections into the eye or steroid implants placed in the eye
• People who have had a device implanted inside the eye (not counting standard lens implants used in cataract surgery)
• People who have previously had any type of laser treatment for AMD
• People who have received an anti-VEGF injection other than ranibizumab within 1 month before the randomisation visit
• People who have previously had injections into the eye to treat a condition called geographic atrophy
• People who have a condition affecting specific tissues on the surface of the eye (in the upper-outer area) that could interfere with a special implant device used in this trial

Related to either eye — previous treatments:

• People who have previously been treated with a drug called brolucizumab in either eye
• People who have previously received gene therapy for wet AMD or any other eye disease
• People who have taken part in another clinical study involving an experimental drug or device within 3 months (or a longer period depending on the drug) before the screening visit

Related to the wet AMD lesion itself:

• People who have bleeding under the retina that covers the centre of the fovea (a key part of the eye) and is larger than a certain size at screening
• People who have scarring or tissue loss directly under the fovea
• People whose abnormal blood vessel growth is caused by something other than AMD, such as an eye infection called histoplasmosis, eye injury, a condition called central serous chorioretinopathy, or severe short-sightedness

Related to other eye conditions in the study eye:

• People who have a tear in a layer of the retina called the retinal pigment epithelium
• People who have any other ongoing eye condition inside the eye
• People who have active inflammation inside the eye
• People who have a history of bleeding in the gel inside the eye (vitreous haemorrhage)
• People who have a history of the retina becoming detached in a specific way (rhegmatogenous retinal detachment)
• People who have had certain types of retinal tears within 3 months before the randomisation visit
• People who have had a specific type of eye surgery called pars plana vitrectomy
• People whose eye has no natural lens and no lens capsule remaining
• People with a high degree of short-sightedness (more than 8 dioptres of myopia, including cases related to prior refractive or cataract surgery)
• People who have had any surgery inside the eye, including cataract surgery, within 3 months before the randomisation visit
• People with uncontrolled high pressure in the eye or uncontrolled glaucoma
• People who have had certain glaucoma surgeries, including filtering surgery, tube shunts, or minimally invasive glaucoma procedures
• People who have had a corneal transplant

Related to the other (non-study) eye:

• People whose other eye has no functional vision

Related to either eye:

• People with any history of a condition called uveitis (inflammation inside the eye)
• People with an active eye infection such as conjunctivitis, keratitis, scleritis, or endophthalmitis

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