Actively Recruiting
Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)
Led by Association for Innovation and Biomedical Research on Light and Image · Updated on 2026-02-06
120
Participants Needed
31
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 50 years or older at consent
- Caucasian ethnicity
- Ability to follow study protocol as judged by investigator
- For women of childbearing potential: agreement to abstain or use reliable contraception during treatment and for 3 months after last dose
- Clear ocular media and adequate pupil dilation for retinal imaging
- Confirmed diagnosis of treatment-naive symptomatic macular PCV by Reading Centre
- Best corrected visual acuity between 24 and 78 ETDRS letters (approximate Snellen 20/32 to 20/320) in study eye at Day 1
You will not qualify if you...
- Use of investigational therapy within 3 months before Day 1
- Major illness or surgery within 1 month before screening
- Active cancer within 12 months before Day 1 except certain stable or treated cancers
- Continuous use of systemic anti-VEGF or drugs causing macular edema
- Systemic treatment for infection on Day 1
- Uncontrolled high blood pressure on Day 1
- Stroke or myocardial infarction within 6 months before Day 1
- Severe allergic reaction to biologics or study medications
- Pregnancy, breastfeeding, or planning pregnancy during study or 28 days after last dose
- History of uveitis or active ocular inflammation or infection in either eye
- Macular conditions unrelated to PCV affecting vision in study eye
- Retinal pigment epithelial tear in study eye
- Narrow-angle glaucoma without prior iridotomy
- Large subretinal hemorrhage or fibrosis involving the fovea
- Other intraocular conditions reducing vision or requiring treatment
- Prior or concurrent treatments for PCV or retinal diseases in study eye
- Recent cataract surgery or related treatments within 3 months before Day 1
- Any intraocular surgery prior to Day 1
- Use of IVT anti-VEGF agents other than study drug
- Use of intraocular steroids or chronic topical corticosteroids
- Use of macular photocoagulation or photodynamic therapy with verteporfin
- Non-functioning fellow eye or monocular status at screening and Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Italy
Not Yet Recruiting
2
Medical Retina Service, Operative Unit Ophthalmology - MultiMedica Spa (IRCCSMM)
Milan, Italy
Not Yet Recruiting
3
ASST-Fatebenefratelli-Sacco P.O.L. Sacco
Milan, Italy
Not Yet Recruiting
4
Eye Unit, University Hospital Maggiore della Carità
Novara, Italy
Not Yet Recruiting
5
IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS,
Roma, Italy
Actively Recruiting
6
Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffaele
San Raffaele, Italy
Not Yet Recruiting
7
Department of Ophthalmology, University of Udine
Udine, Italy
Not Yet Recruiting
8
Espaço Médico de Coimbra
Coimbra, Portugal
Actively Recruiting
9
Ophthalmology Department, Hospitais Universidade de Coimbra,
Coimbra, Portugal
Actively Recruiting
10
Unidade Local de Saúde da Região de Leiria, E.P.E.
Leiria, Portugal
Actively Recruiting
11
almPRIMUM- Serviços de Oftalmologia Médica e Cirúrgica
Lisbon, Portugal
Actively Recruiting
12
Instituto de Retina e Diabetes Ocular de Lisboa (IRL),
Lisbon, Portugal
Actively Recruiting
13
Serviço de Oftalmologia, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria
Lisbon, Portugal
Actively Recruiting
14
Unidade Local de Saúde São José
Lisbon, Portugal
Actively Recruiting
15
ULS-LOD - Hospital Beatriz Ângelo
Loures, Portugal
Actively Recruiting
16
Department of Ophthalmology, Porto Medical School / Hospital S. João
Porto, Portugal
Not Yet Recruiting
17
Serviço Oftalmologia, Centro Hospitalar Universitário de Santo António, E.P.E.,
Porto, Portugal
Actively Recruiting
18
Centro de Oftalmologia Barraquer
Barcelona, Spain
Actively Recruiting
19
Hospital Vall d'Hebrón Department of Ophthalmology
Barcelona, Spain
Not Yet Recruiting
20
Institut Català de Retina (ICR), Clinical Trial Unit
Barcelona, Spain
Actively Recruiting
21
Valles Ophthalmology Research, S.L., Hospital General de Catalunya,
Barcelona, Spain
Not Yet Recruiting
22
Department of Ophthalmology, Fundación Jiménez Díaz University Hospital
Madrid, Spain
Not Yet Recruiting
23
Instituto Oftalmologico Fernandez-Veja
Oviedo, Spain
Not Yet Recruiting
24
Instituto Oftalmologico Fernandez-Veja
Oviedo, Spain
Not Yet Recruiting
25
Fundación de Oftalmología Médica de la Comunitat Valenciana (Fom)
Valencia, Spain
Not Yet Recruiting
26
Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust,
Gloucester, United Kingdom
Actively Recruiting
27
Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital
Liverpool, United Kingdom
Actively Recruiting
28
Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust
London, United Kingdom
Actively Recruiting
29
ICORG - Imperial College Ophthalmologic Research Group
London, United Kingdom
Not Yet Recruiting
30
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
31
Wolverhampton and Midland Counties Eye Infirmary, New Cross Hospital
Wolverhampton, United Kingdom
Not Yet Recruiting
Research Team
J
Joana F Tavares, PhD
CONTACT
L
Liliana C Soares, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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