Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Change from Baseline in BCVA in the study eye to Week 40 or 44 or 48 — From Baseline through Week 40 or 44 or 48
Best Corrected Visual Acuity (BCVA) is measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena | Milan | Italy | Not Yet Recruiting |
| Medical Retina Service, Operative Unit Ophthalmology - MultiMedica Spa (IRCCSMM) | Milan | Italy | Not Yet Recruiting |
| ASST-Fatebenefratelli-Sacco P.O.L. Sacco | Milan | Italy | Not Yet Recruiting |
| Eye Unit, University Hospital Maggiore della Carità | Novara | Italy | Not Yet Recruiting |
| IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS, | Roma | Italy | Recruiting |
| Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffaele | San Raffaele | Italy | Not Yet Recruiting |
| Department of Ophthalmology, University of Udine | Udine | Italy | Not Yet Recruiting |
| Espaço Médico de Coimbra | Coimbra | Portugal | Recruiting |
| Ophthalmology Department, Hospitais Universidade de Coimbra, | Coimbra | Portugal | Recruiting |
| Unidade Local de Saúde da Região de Leiria, E.P.E. | Leiria | Portugal | Recruiting |
| almPRIMUM- Serviços de Oftalmologia Médica e Cirúrgica | Lisbon | Portugal | Recruiting |
| Instituto de Retina e Diabetes Ocular de Lisboa (IRL), | Lisbon | Portugal | Recruiting |
| Serviço de Oftalmologia, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria | Lisbon | Portugal | Recruiting |
| Unidade Local de Saúde São José | Lisbon | Portugal | Recruiting |
| ULS-LOD - Hospital Beatriz Ângelo | Loures | Portugal | Recruiting |
| Department of Ophthalmology, Porto Medical School / Hospital S. João | Porto | Portugal | Not Yet Recruiting |
| Serviço Oftalmologia, Centro Hospitalar Universitário de Santo António, E.P.E., | Porto | Portugal | Recruiting |
| Centro de Oftalmologia Barraquer | Barcelona | Spain | Recruiting |
| Hospital Vall d'Hebrón Department of Ophthalmology | Barcelona | Spain | Not Yet Recruiting |
| Institut Català de Retina (ICR), Clinical Trial Unit | Barcelona | Spain | Recruiting |
| Valles Ophthalmology Research, S.L., Hospital General de Catalunya, | Barcelona | Spain | Not Yet Recruiting |
| Department of Ophthalmology, Fundación Jiménez Díaz University Hospital | Madrid | Spain | Not Yet Recruiting |
| Instituto Oftalmologico Fernandez-Veja | Oviedo | Spain | Not Yet Recruiting |
| Instituto Oftalmologico Fernandez-Veja | Oviedo | Spain | Not Yet Recruiting |
| Fundación de Oftalmología Médica de la Comunitat Valenciana (Fom) | Valencia | Spain | Not Yet Recruiting |
| Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust, | Gloucester | United Kingdom | Recruiting |
| Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital | Liverpool | United Kingdom | Recruiting |
| Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust | London | United Kingdom | Recruiting |
| ICORG - Imperial College Ophthalmologic Research Group | London | United Kingdom | Not Yet Recruiting |
| University Hospital Southampton NHS Foundation Trust | Southampton | United Kingdom | Recruiting |
| Wolverhampton and Midland Counties Eye Infirmary, New Cross Hospital | Wolverhampton | United Kingdom | Not Yet Recruiting |
More Association for Innovation and Biomedical Research on Light and Image trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06709339 on ClinicalTrials.gov ↗ ← All trials in Spain