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Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

NCT07403825 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-28

No results posted yet for this study

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

Interventions

DRUG

Vabysmo 6 MG in 0.05 ML Injection

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.

Sponsors & Collaborators

  • Roche Farma, S.A

    collaborator INDUSTRY

  • Biobizkaia Health Research Institute

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07403825 on ClinicalTrials.gov