Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

NCT07403825 | Recruiting Phase 4

• 1 other identifier: FARIDUO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Macular Degeneration, Age Related

Outcome Measures

Primary Outcomes (1)

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

  The percentage of patients with resolution of SHRM at week 16.

  finish to the clinical trial

Study Arms (1)

Vabysmo

EXPERIMENTAL

Experimental arm

Drug: Vabysmo 6 MG in 0.05 ML Injection

Interventions

Vabysmo 6 MG in 0.05 ML Injection DRUG

The study drug, Faricimab (Vabysmo®), will be administered at a dose of 6 mg/0.05 ml, by intravitreal injection, following the indications in the product's technical data sheet.

Also known as: Faricimab

Vabysmo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Roche Farma, S.A: collaborator
• Biobizkaia Health Research Institute: lead

Study Sites (10)

Hospital Arruzafa

Córdoba, Andalusia, 14012, Spain

RECRUITING

Hospital Universitario Basurto

Bilbao, Bizkaia, 48013, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, 47003, Spain

RECRUITING

Hospital Universitario Nuestra Señora del Perpétuo Socorro

Albacete, Castille-La Mancha, 02006, Spain

RECRUITING

Clinica Barraquer

Barcelona, Catalonia, 08021, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

RECRUITING

Instituto Oftalmologico Fernandez-Vega

Oviedo, Principality of Asturias, 33012, Spain

RECRUITING

Oftalvist Valencia

Burjassot, Valencia, 46100, Spain

RECRUITING

Hospital General Universitario Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Injections; faricimab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

ES (10)