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Looking for participantsPhase4

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

NCT ID: NCT06709339

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Faricimab Injection [Vabysmo] (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Faricimab Injection [Vabysmo] — drug: The investigational medicinal product (IMP) for this study is faricimab (RO6867461), as per clinical practice.
Patient visit burden
Not specified by the sponsor

In plain English

This study, called MONDEGO, looks at how well a medicine called faricimab works, how safe it is, and how long its effects last in Caucasian patients with polypoidal choroidal vasculopathy (PCV). PCV is an eye condition that affects the light-sensitive part at the back of the eye (the retina). The study is sponsored by the Association for Innovation and Biomedical Research on Light and Image.

Who can take part

  • Age 50 or over when signing the consent form
  • Caucasian
  • Able and willing to follow the study plan, in the researcher's opinion
  • Women who could become pregnant must avoid sex or use very reliable contraception during treatment and for at least 3 months after the last dose of faricimab
  • Clear enough eyes and wide enough pupils to take good-quality pictures of the back of the eye
  • A confirmed diagnosis of active PCV affecting the central part of the retina, shown on a special dye test (indocyanine green angiography) and other eye images
  • Eyesight score between certain limits set by the study (roughly 20/32 to 20/320 on a Snellen chart), tested on day 1

Who may not be able to

  • Treatment with any experimental therapy in the 3 months before the study starts
  • A serious illness or major operation in the month before screening
  • Cancer in the past 12 months (with some exceptions, such as certain treated skin, cervical and low-risk prostate cancers)
  • Ongoing use of certain medicines, including anti-VEGF drugs given through the bloodstream and drugs known to cause swelling at the back of the eye (fingolimod, tamoxifen)
  • Treatment for a suspected or active infection on day 1 (some preventive antibiotics may be allowed after discussion)
  • Blood pressure that is not controlled (top number over 180 or bottom number over 100 while resting) on day 1
  • A stroke or heart attack in the 6 months before day 1
  • Any other condition that, in the researcher's view, makes the study drug unsafe, affects the results, or raises the risk of problems
  • Severe allergic reactions to biologic medicines, or allergy to any part of the faricimab injection, the dyes, dilating drops, or numbing and antibiotic preparations used in the study
  • Pregnant, breastfeeding, or planning to become pregnant during the study or within 28 days after the last dose
  • A history of uveitis (inflammation inside the eye) in either eye
  • Active eye inflammation or infection in or around either eye on day 1
  • Other eye conditions affecting the central retina that are not PCV, or that could affect vision or need treatment during the study
  • A tear in a layer at the back of the eye involving the central retina on day 1
  • Narrow-angle glaucoma that has not been treated (laser treatment may allow participation after referral to a specialist)
  • Large bleeding under the retina, or scarring or thinning of more than half the affected area, involving the central part of the retina
  • Bleeding into the eye on day 1
  • Advanced or uncontrolled glaucoma
  • Short-sightedness of more than 8 dioptres
  • Any previous treatment for PCV or other retinal diseases, including eye injections, lasers, light-activated therapy, or eye surgery
  • Cataract surgery or its complications treated within 3 months before day 1
  • Certain other eye operations, such as vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy
  • Regular use of certain injected or steroid eye treatments, or light-activated therapy, during the study
  • A non-functioning other eye (very poor vision or the eye is missing) at both screening and day 1

What taking part involves

  • • The study medicine faricimab, given by injection into the eye
  • • Not stated — ask the trial team about how many injections are given and how often

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
50 Years to 90 Years
Who
All
Number of participants
120
Started
2025-08-06
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for polypoidal choroidal vasculopathy
  • • Phase4 - 120 participants
  • • The goal of this clinical trial is to assess the efficacy, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV)

Who can take part?

  • • Ages 50 Years to 90 Years
  • • Diagnosed with polypoidal choroidal vasculopathy

Where?

  • • Gloucester - Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust,
  • • Liverpool - Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital
  • • London - Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust
  • • London - ICORG - Imperial College Ophthalmologic Research Group
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Polypoidal choroidal vasculopathy (PCV) was first described in 1982 by Yannuzzi as a choroidal vasculopathy leading to haemorrhagic and exudative macular degeneration. More than four decades later, the pathogenesis of the disease remains uncertain with authors considering PCV a subtype of neovascular age-related macular degeneration (nAMD) while others advocate a separate clinical entity and adequate treatment is still an unmet need. Several studies have reported an association between PCV and major and minor interethnic classification differences regarding morphological alterations, prevalence, genetic associations, lesion location, and results after anti-vascular endothelial growth factor (VEGF) treatment, among others. For instance, the reported prevalence of PCV in patients with neovascular AMD ranges from 4% to 9,8% in Caucasians and from 22% to 55% in Asians. However, a recent study reported a much higher prevalence in Caucasians (22,1%), suggesting that PCV may actually be underdiagnosed in this population. Today, intravitreal (IVT) anti-VEGF therapy plays a key role in the management of PCV and has become the standard of care. The anti-permeability property of anti-VEGF agents, such as aflibercept and ranibizumab, play a role in reducing the exudation from abnormal choroidal vessels and polypoidal lesions, thereby decreasing the subretinal fluid and preserving vision. Although the current standard of care has demonstrated clinical benefit for patients with PCV, many limitations exist in understanding the disease as a result of its heterogeneity in clinical features and treatment outcomes. The burden of frequent injections, incomplete polypoidal lesion closure, and the risk and unpredictability of lesion relapse reinforce the need to develop new treatments for patients with PCV. This population is at risk of disease relapse, retinal haemorrhage, and vision loss, and is appropriate for inclusion in this clinical trial. Faricimab is a novel humanized bispecific Immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to VEGF-A and angiopoietin-2 (Ang-2). Faricimab was studied for the treatment of neovascular AMD (nAMD) in the global Phase III Studies TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300) and is currently being studied in the long-term extension Study AVONELLE-X (ClinicalTrials.gov identifier: NCT04777201). The TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300) studies consistently showed that faricimab, given at intervals of up to 16 weeks, offered non-inferior vision gains compared with aflibercept, given every 2 months in the first year. Approximately 50% of participants eligible for extended dosing with faricimab were able to be treated every 4 months, and nearly 80% of participants every 3 months or longer. However, patients with symptomatic macular PCV were under-represented in the faricimab Phase III pivotal Studies TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300). The purpose of this study is to assess the efficacy, durability, and safety of faricimab 6 mg IVT administered at up to 24-week intervals in the treatment-naive study eye of Caucasian patients with symptomatic macular PCV. This study will add to the evidence base for the benefit-risk profile of faricimab IVT injection in Caucasian patients with symptomatic macular PCV. The study consists of a screening period of up to 28 days (Days -28 to -1) in length and an approximately 100-week study treatment period consisting of a Treatment Initiation period (Weeks 1-12) and the treat and extend (T\&E) regimen period (Weeks 20-Week 100).

Polypoidal Choroidal Vasculopathy

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 90 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ medical or surgical intervention during the study

What the study is looking for

  • ✓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
See the full criteria
General Inclusion Criteria: 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. Ocular Inclusion Criteria for study eye: * 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 * Presence of exudative or haemorrhagic features involving the macula as identified by the investigator using multimodal images. * BCVA scores of 78-24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters \[see the BCVA Standard Operational Procedures (SOP) for additional details\] on study Day 1. General Exclusion Criteria 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 Ocular Exclusion Criteria Potential participants are excluded from the study if any of the following criteria apply to both eyes: * History of idiopathic or autoimmune-associated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1 Participants who meet any of the following ocular criteria for the study eye will be excluded from study entry: * Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular haemorrhage, IRF, or SRF * Retinal pigment epithelial tear involving the macula on study Day 1 * Diagnosis with or suspected of having narrow-angle glaucoma who have not undergone iridotomy. The inclusion of these patients will be conditional upon prior referral to the relevant specialist for appropriate treatment to enable participation in the study. * On FFA/colour fundus photograph (CFP): * Subretinal haemorrhage of \> 4 macular photocoagulation study disc area and/or that involves the fovea * Fibrosis or atrophy of \> 50% of the total lesion area and/or that involves the fovea * Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study * Current vitreous haemorrhage on study Day 1 * Advanced/or uncontrolled glaucoma * Spherical equivalent of refractive error demonstrating more than 8 dioptres of myopia * Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin PDT, diode laser, transpupillary thermotherapy, or ocular surgical intervention * Any cataract surgery or treatment for complications of cataract surgery with steroids or yttrium-aluminum-garnet (YAG) laser capsulotomy within 3 months prior to study Day 1 * Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy) * Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases * Continuous use of any medications and treatments indicated below: * IVT anti-VEGF agents (other than study-assigned faricimab) * IVT, periocular (subtenon), steroid implants (i.e., Ozurdex®, Illuvien®), or chronic topical ocular corticosteroids (defined as continuous usage for 100 days or longer) * Concurrent use of any macular photocoagulation or PDT with verteporfin Participants who have a non-functioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry.

Where Is This Study? (6 UK sites)

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

Gloucester, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Professional Services

ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467

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
Hospital R&D contact (matched)

R&I Professional Services

ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467

ICORG - Imperial College Ophthalmologic Research Group

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Wolverhampton and Midland Counties Eye Infirmary, New Cross Hospital

Wolverhampton, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Joana F Tavares, PhD

Sponsor contact

CONTACT

351239480137 mondego@aibili.pt

Liliana C Soares, MsC

Sponsor contact

CONTACT

351239480112 lcarvalho@aibili.pt
Data sourced from ClinicalTrials.gov · Last verified: 2026-02