Faricimab for Subretinal hyperreflective material | Age-related macular degeneration

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Eyes with type 1, aneurysmal type 1 and type 3 MNV\n- Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum)\n- Eyes with ocular media opacity\n- Patients with other retinal diseases that could compromise the best corrected visual acuity and interfere in the values of retinal parameters\n- Any ocular or neurological condition (including cognitive impairment) 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\n- People who are participating or will participate in any type of clinical trial\n- Pregnant women\n- Breastfeeding women\n- Men and 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"}

Primary endpoints

• {"endpoint_text":"- Resolution of SHRM at week 16","definition_or_measurement_approach":"To determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16"}

Spain

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

163

Number Of Sites

10

Number Of Participants

100

Primary sponsor

Full Name

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Roche Farma S.A.","duties_or_roles":"Site of certification and importation for Vabysmo","organisation_type":"Pharmaceutical company"}