Not Yet RecruitingPhase 4

Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

100 participantsStarted 2026-04

Plain-language 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 endothelial growth factor) drugs have been used for the treatment of type 2 and mixed 1 and 2 types of MNV. Following treatment, a reduction in SHRM has been observed, although results between studies vary between 34% and 56%. Improvements in best-corrected visual acuity are also achieved in eyes with type 2 MNV with anti-VEGF therapy.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

What they're measuring

to assess the resolution of subretinal hyperreflective material (SHRM) at week 16

Timeframe: finish to the clinical trial

Trial details

NCT IDNCT07403825

SponsorBiobizkaia Health Research Institute

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-10