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RecruitingPHASE4INTERVENTIONAL

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

This research is investigating a new treatment called faricimab (Vabysmo) for an eye condition known as polypoidal choroidal vasculopathy (PCV). This condition can cause bleeding and fluid leakage in the back of the eye, potentially affecting your vision. The study aims to understand how effective, safe, and long-lasting faricimab is for white patients with PCV. Currently, PCV is often treated with frequent eye injections, which can be a burden. Researchers hope faricimab could reduce how often these injections are needed, improve vision, and offer a better solution for patients. Participants will receive eye examinations and faricimab injections, with the treatment schedule adjusted based on their individual needs.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Association for Innovation and Biomedical Research on Light and Image
Enrolment target
120
Start
06 Aug 2025
Estimated completion
01 Aug 2028

What is this study about?

This study is looking into a new treatment called faricimab, also known as Vabysmo, for an eye condition called polypoidal choroidal vasculopathy, or PCV. PCV affects the back of the eye, causing abnormal blood vessels to grow. These vessels can leak fluid and blood, which can lead to blurred vision or even vision loss. While we have treatments for PCV, such as other eye injections, doctors are still trying to find better ways to manage the condition, especially for white patients where PCV might be underdiagnosed.

Faricimab is a newer medication that doctors hope will be more effective and require less frequent injections than current treatments. This study specifically wants to see if faricimab improves vision in white patients with PCV and how long these benefits last. It also wants to check if the treatment is safe and well-tolerated. The current treatments, while helpful, often require many doctor visits for injections, which can be difficult for patients. If faricimab works well and lasts longer, it could mean fewer visits and less burden for people living with PCV.

Researchers are focusing on white patients because PCV seems to affect different groups of people in slightly different ways. By understanding how faricimab works for this specific group, they can ensure that the treatment is effective across different populations. The ultimate goal is to find a treatment that helps to better control PCV, prevent further vision loss, and improve the quality of life for patients.

Key takeaways

  • Tests a new eye injection (Faricimab/Vabysmo) for PCV.
  • Aims to improve vision and reduce injection frequency.
  • Focuses on white (Caucasian) patients aged 50-90.
  • Involves regular eye exams and personalised injection schedule.
  • Participation is voluntary; you can withdraw at any time.
  • Could offer a new way to manage PCV better.

Who may be eligible?

To join this study, you need to be at least 50 years old. You must also be of white (Caucasian) ethnic background. The doctors leading the study will need to agree that you're suitable and can follow the study plan.

If you are a woman who could potentially become pregnant, you'll need to use very reliable birth control during the study and for at least three months after your last treatment. This means methods like the pill, an implant, or an IUD are acceptable, but natural family planning methods are not.

Participation is open to both men and women. The study is for people aged between 50 and 90 years old.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 50 years old or older?
  2. Are you of white (Caucasian) ethnic background?
  3. Do you have a diagnosis of polypoidal choroidal vasculopathy (PCV)?
  4. Are you able to attend regular appointments and follow study instructions?
  5. If you're a woman who could become pregnant, are you willing to use reliable birth control during the study?
Answer every question to see your result.

What does participation involve?

If you join this study, you will have regular eye check-ups and safety assessments. You will receive injections of faricimab (Vabysmo) directly into your eye. The timing of these injections will be tailored to your individual needs, meaning your doctor will decide how often you need them based on how your eye responds. This is called a "treat and extend" approach, where the time between injections might get longer if your condition is stable. The study will involve a series of visits over a period of time to monitor your eyesight, check for any side effects, and administer your treatment. The exact total duration of your participation will depend on your individual treatment plan.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a new treatment that might improve your vision and require fewer injections than current options for PCV. However, as with any medical treatment, there are potential risks, including side effects from the eye injections, such as eye pain, redness, or infection, though these are generally rare. The doctors will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
    Verified postcode
    Milan, Italy· Not yet recruiting
  • Medical Retina Service, Operative Unit Ophthalmology - MultiMedica Spa (IRCCSMM)
    Verified postcode
    Milan, Italy· Not yet recruiting
  • ASST-Fatebenefratelli-Sacco P.O.L. Sacco
    Verified postcode
    Milan, Italy· Not yet recruiting
  • Eye Unit, University Hospital Maggiore della Carità
    Verified postcode
    Novara, Italy· Not yet recruiting
  • IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS,
    Verified postcode
    Roma, Italy· Recruiting
  • Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffaele
    Verified postcode
    San Raffaele, Italy· Not yet recruiting
  • Department of Ophthalmology, University of Udine
    Verified postcode
    Udine, Italy· Not yet recruiting
  • Espaço Médico de Coimbra
    Verified postcode
    Coimbra, Portugal· Recruiting
  • Ophthalmology Department, Hospitais Universidade de Coimbra,
    Verified postcode
    Coimbra, Portugal· Recruiting
  • Unidade Local de Saúde da Região de Leiria, E.P.E.
    Verified postcode
    Leiria, Portugal· Recruiting
  • almPRIMUM- Serviços de Oftalmologia Médica e Cirúrgica
    Verified postcode
    Lisbon, Portugal· Recruiting
  • Instituto de Retina e Diabetes Ocular de Lisboa (IRL),
    Verified postcode
    Lisbon, Portugal· Recruiting

Common questions

What is PCV?

PCV, or polypoidal choroidal vasculopathy, is an eye condition where abnormal blood vessels grow and leak fluid or blood at the back of your eye, potentially affecting your vision.

What is Faricimab (Vabysmo)?

Faricimab (Vabysmo) is a new medicine given by injection into the eye, which researchers hope will help treat PCV more effectively and with less frequent doses.

Will I have to pay to be in the study?

No, you should not have to pay for the study treatment or assessments. Clinical trials are typically funded by the researchers or pharmaceutical companies.

How often will I need injections?

The frequency of injections will be tailored to your individual needs. The aim is to extend the time between injections as much as possible if your eye condition is stable.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your future medical care.

How to find out more

Joana F Tavares, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study to Investigate the Efficacy, Safety and Durability of …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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