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

NCT06709339 | Recruiting Phase 4

• 2 other identifiers: ECR-AMD-2024-152024-515640-22-00
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 31

Brief 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.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Faricimab; Caucasian patients; PCV; Durability; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in BCVA in the study eye to 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.

  From Baseline through Week 40 or 44 or 48

Secondary Outcomes (23)

• Change from Baseline in BCVA in the Study

  From baseline through last treatment visit (up to 100 weeks)

• Change from Baseline in BCVA in the Study Eye to the last treatment visit

  From Baseline through last treatment visit (up to 100 weeks)

• Change From Baseline in BCVA in the Study Eye Over Time

  Over time (up to 104 weeks)

• Proportion of Participants Gaining Greater Than or Equal to (≥)15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Averaged Over Time

  Over time (up to 104 weeks)

• Proportion of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

  Over time (up to 104 weeks)

Study Arms (1)

Faricimab

EXPERIMENTAL

This open-label, single-arm study will evaluate the efficacy, safety, and durability of Faricimab Injection \[Vabysmo\] 6 mg anti-VEGF IVT in Caucasian patients with symptomatic macular PCV.

Drug: Faricimab Injection [Vabysmo]

Interventions

Faricimab Injection [Vabysmo] DRUG

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

Faricimab

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential participants are eligible to be included in the study only if all of the following criteria apply:
• Signed ICF
• Age ≥ 50 years at the time of signing the ICF
• Caucasian
• Participants who are able to comply with the study protocol, in the investigator's judgment
• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:
• Female participants must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year, during the treatment period and for at least 3 months after the final dose of faricimab.
• A female participant is considered to be of childbearing potential if she is post-menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
• Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• The reliability of sexual abstinence should be evaluated concerning the duration of the clinical trial and the preferred and usual lifestyle of the individual.
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.
• If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.
• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
• Confirmed diagnosis, by the Reading Centre, of naïve symptomatic macular PCV defined by the following:
• Active macular polypoidal lesions shown by ICGA AND

You may not qualify if:

• Potential participants are excluded from the study if any of the following criteria apply:
• Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
• Any major illness or major surgical procedure within 1 month before screening
• Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 (Grade Group of 1) and a stable prostate-specific antigen for ≥ 12 months
• Continuous use of any medications and treatments indicated below:
• Systemic anti-VEGF therapy
• Systemic drugs known to cause macular oedema (fingolimod, tamoxifen)
• Other experimental therapies (except those comprising vitamins and minerals) and therapies that claim to have an effect on macular pathology (e.g., kallidinogenase)
• Systemic treatment for suspected or active systemic infection on study Day 1
• Ongoing use of prophylactic antibiotic therapy may be acceptable after discussion with the Medical Monitor.
• Uncontrolled blood pressure, defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg while the participant is at rest on study Day 1
• History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1
• History of other diseases, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the IMP or that might affect the interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anaesthetic and antimicrobial preparations used by a participant during the study
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead

Study Sites (31)

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

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

faricimab

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joana F Tavares, PhD

CONTACT

351239480137; mondego@aibili.pt

Liliana C Soares, MsC

CONTACT

351239480112; lcarvalho@aibili.pt

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted in adult Caucasian participants with symptomatic macular PCV, a subtype of nAMD, which was under-represented in the faricimab Phase III pivotal Studies TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300) where less than 2% of the enrolled participants with nAMD were diagnosed with PCV and no Caucasian participants with symptomatic macular PCV were identified in the mentioned pivotal Studies.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

PT (10); GB (6); IT (7); ES (8)