A Study Testing How Well Faricimab Works in Patients with Subretinal Hyperreflective Material Associated with Neovascular Membranes in the Eye

This clinical trial is studying a condition called subretinal hyperreflective material, which is a type of abnormal tissue that can develop in the eye. This condition is associated with neovascular membranes, which are abnormal blood vessels that grow beneath the retina, the light-sensitive tissue at the back of the eye. These membranes are classified as type 2 or mixed type, meaning they involve different patterns of abnormal blood vessel growth. This condition is related to age-related macular degeneration, a disease that affects central vision and is common in older adults. The treatment being studied is Vabysmo, which contains the active substance faricimab. This medication belongs to a group of medicines called antineovascularization agents, which work to stop the growth of abnormal blood vessels in the eye. The medicine is given as an injection directly into the eye, a procedure called intravitreal injection.

The purpose of this study is to determine how many patients have complete clearing of the subretinal hyperreflective material after 16 weeks of treatment with faricimab. The study will use special imaging techniques called multimodal imaging to examine the eye and assess changes in this abnormal tissue. Multimodal imaging means using different types of eye scans and photographs to get detailed pictures of the structures inside the eye. This helps doctors see whether the treatment is working to remove the abnormal material from beneath the retina.

During the study, patients will receive faricimab injections into the affected eye according to the approved treatment schedule. The study will monitor patients over time to see if the abnormal tissue resolves and to evaluate how well the treatment works. The medication will be given to patients who have not previously received treatment for this condition, meaning their eyes are treatment-naive. The total treatment period for each patient will last up to three years, though the main assessment of whether the abnormal tissue has cleared will happen at week 16.