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RECRUITING
NCT06709339
PHASE4

Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)

Sponsor: Association for Innovation and Biomedical Research on Light and Image

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the efficacy, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is: To evaluate the efficacy of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV. Participants will undergo ophthalmic examination, safety assessment and treatment with faricimab according to a patient specific treat and extend regimen.

Official title: A Phase IV, Multicentre, Open-label, Single-arm Study to Investigate the Efficacy, Safety and Durability of Faricimab (RO6867461) in Caucasian Patients With Polypoidal Choroidal Vasculopathy

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-08-06

Completion Date

2028-08

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

Faricimab Injection [Vabysmo]

The investigational medicinal product (IMP) for this study is faricimab (RO6867461), as per clinical practice. No control treatment will be used for this study

Locations (31)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena

Milan, Italy

Medical Retina Service, Operative Unit Ophthalmology - MultiMedica Spa (IRCCSMM)

Milan, Italy

ASST-Fatebenefratelli-Sacco P.O.L. Sacco

Milan, Italy

Eye Unit, University Hospital Maggiore della Carità

Novara, Italy

IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS,

Roma, Italy

Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffaele

San Raffaele, Italy

Department of Ophthalmology, University of Udine

Udine, Italy

Espaço Médico de Coimbra

Coimbra, Portugal

Ophthalmology Department, Hospitais Universidade de Coimbra,

Coimbra, Portugal

Unidade Local de Saúde da Região de Leiria, E.P.E.

Leiria, Portugal

almPRIMUM- Serviços de Oftalmologia Médica e Cirúrgica

Lisbon, Portugal

Instituto de Retina e Diabetes Ocular de Lisboa (IRL),

Lisbon, Portugal

Serviço de Oftalmologia, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria

Lisbon, Portugal

Unidade Local de Saúde São José

Lisbon, Portugal

ULS-LOD - Hospital Beatriz Ângelo

Loures, Portugal

Department of Ophthalmology, Porto Medical School / Hospital S. João

Porto, Portugal

Serviço Oftalmologia, Centro Hospitalar Universitário de Santo António, E.P.E.,

Porto, Portugal

Centro de Oftalmologia Barraquer

Barcelona, Spain

Hospital Vall d'Hebrón Department of Ophthalmology

Barcelona, Spain

Institut Català de Retina (ICR), Clinical Trial Unit

Barcelona, Spain

Valles Ophthalmology Research, S.L., Hospital General de Catalunya,

Barcelona, Spain

Department of Ophthalmology, Fundación Jiménez Díaz University Hospital

Madrid, Spain

Instituto Oftalmologico Fernandez-Veja

Oviedo, Spain

Instituto Oftalmologico Fernandez-Veja

Oviedo, Spain

Fundación de Oftalmología Médica de la Comunitat Valenciana (Fom)

Valencia, Spain

Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust,

Gloucester, United Kingdom

Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital

Liverpool, United Kingdom

Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust

London, United Kingdom

ICORG - Imperial College Ophthalmologic Research Group

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Wolverhampton and Midland Counties Eye Infirmary, New Cross Hospital

Wolverhampton, United Kingdom