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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (6 UK sites)
Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust,
Gloucester, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Clinical 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
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467ICORG - 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
How to Get in Touch
Joana F Tavares, PhD
Sponsor contactCONTACT
Liliana C Soares, MsC
Sponsor contactCONTACT
