Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material
Whose aim is to: Determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16. This study is intended to be performed in the ophthalmology departments or ophthalmology clinics of the participating sites, located in Spain. Macular degeneration is an eye disease characteri
| Condition(s) | Macular Degeneration, Age Related |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Whose aim is to: Determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16. This study is intended to be performed in the ophthalmology departments or ophthalmology clinics of the participating sites, located in Spain. Macular degeneration is an eye disease characterised by progressive damage to the macula leading to a loss of central vision. There are two types of macular degeneration, dry and wet or exudative. The prevalence of the latter in Spain is 1.9% in people aged 65 and over. Among the subtypes of macular neovascularisation (MNV), type 2 is rare (9%), with the majority being mixed type 1 and 2 cases (13.5%). SHRM is present in about 77% of eyes with neovascular age-related macular degeneration (AMD). Different anti-VEGF (vascular |
| Who can participate | 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-correcte |
| Ages | 50 Years |
| Sex | All |
| Lead sponsor | Biobizkaia Health Research Institute |
| Locations | Córdoba, Andalusia, Spain; Bilbao, Bizkaia, Spain; Valladolid, Castille and León, Spain; Albacete, Castille-La Mancha, Spain; Barcelona, Catalonia, Spain; Madrid, Madrid, Spain (+4 more sites) |
| Start date | 2026-05-25 |
| NCT ID | NCT07403825 |
| Official listing | https://clinicaltrials.gov/study/NCT07403825 |