Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

May 25, 2026 updated by: Biobizkaia Health Research Institute

Efficacy of Faricimab in Patients With Subretinal Hyperreflective Material Associated With Type 2 or Mixed Neovascular Membranes Assessed by Multimodal Imaging

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this phase IV, multicentre, prospective, longitudinal, uncontrolled, prospective clinical trial, patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab. It is an injectable humanised antibody that acts on two different pathways, by neutralising both Ang-2 and VEGF-A. It is indicated for the treatment of adult patients with neovascular AMD, patients with visual impairment due to diabetic macular oedema or patients with visual impairment due to macular oedema secondary to retinal vein occlusion. It may also have a role in stabilising neovascular membranes, as well as a possible antifibrotic effect, reducing the presence of SHRM, after seeing real clinical cases with subretinal haemorrhage and very good response to this drug, probably due to its dual inhibition with Ang-2 suppression.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalusia
      • Córdoba, Andalusia, Spain, 14012
    • Bizkaia
    • Castille and León
      • Valladolid, Castille and León, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
    • Castille-La Mancha
      • Albacete, Castille-La Mancha, Spain, 02006
        • Recruiting
        • Hospital Universitario Nuestra Señora del Perpétuo Socorro
        • Contact:
    • Catalonia
      • Barcelona, Catalonia, Spain, 08021
        • Recruiting
        • Clinica Barraquer
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28040
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Puerta de Hierro Majadahonda
        • Contact:
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33012
        • Recruiting
        • Instituto Oftalmologico Fernandez-Vega
        • Contact:
    • Valencia
      • Burjassot, Valencia, Spain, 46100
        • Recruiting
        • Oftalvist Valencia
        • Contact:
      • Valencia, Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario Valencia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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, 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vabysmo
Experimental arm
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.
Other Names:
  • Faricimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess the resolution of subretinal hyperreflective material (SHRM) at week 16
Time Frame: finish to the clinical trial
The percentage of patients with resolution of SHRM at week 16.
finish to the clinical trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biobizkaia Health Research Institute

Collaborators

Roche Farma, S.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FARIDUO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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