Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

In this phase IV, multicentre, prospective, longitudinal, uncontrolled, prospective clinical trial, patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab. It is an injectable humanised antibody that acts on two different pathways, by neutralising both Ang-2 and VEGF-A. It is indicated for the treatment of adult patients with neovascular AMD, patients with visual impairment due to diabetic macular oedema or patients with visual impairment due to macular oedema secondary to retinal vein occlusion. It may also have a role in stabilising neovascular membranes, as well as a possible antifibrotic effect, reducing the presence of SHRM, after seeing real clinical cases with subretinal haemorrhage and very good response to this drug, probably due to its dual inhibition with Ang-2 suppression.

Inclusion criteria

• People aged 50 and over.
• Diagnosed with bilateral or unilateral AMD.
• Eyes with SHRM and type 2 or mixed (type 1 and 2) neovascular membrane.
• Näive eyes treated with Faricimab following SmPC (summary of product characteristic).
• They agree to participate in the study and sign the informed consent form.

Exclusion criteria

• Eyes with type 1, aneurysmal type 1 and type 3 MNV.
• Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum).
• Eyes with ocular media opacity.
• Patients with other retinal diseases, such as central serous chorioretinopathy, diabetic retinopathy, retinal vascular occlusion, uveitis, myopic maculopathy or any other retinal disease that could compromise the best-corrected visual acuity and interfere with retinal parameters.
• Any neurological condition (including cognitive impairment, stroke, dementia, Parkinson, anxiety or schizophrenia) that, in the opinion of the investigator, would pose a risk to patient's safety or interfere with the assessment, procedures, or completion of the study.
• People who are participating or will participate in any type of clinical trial.
• Pregnant women.
• Breastfeeding women.
• Women* of childbearing potential who are unable or unwilling to use highly effective methods of contraception (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) from the start to the end of the study.

• Woman of childbearing potential: considered as such if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), or has not undergone surgical sterilization (removal of ovaries and/or uterus).