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Study on the Effects of Faricimab for Caucasian Patients with Polypoidal Choroidal Vasculopathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called polypoidal choroidal vasculopathy, which affects the eyes and can lead to vision problems. The study will use a treatment called faricimab, also known by its code name RO6867461. Faricimab is a solution for injection that is administered directly into the eye. The purpose of the study is to evaluate how effective and safe faricimab is in improving vision in patients with this eye condition.

Participants in the study will receive regular injections of faricimab over a period of time. The study will monitor changes in vision, specifically looking at improvements in the ability to see clearly, which is measured by a test called Best Corrected Visual Acuity (BCVA). The study will also observe any changes in the eye's condition, such as the presence of fluid or changes in the thickness of the retina, which is the light-sensitive layer at the back of the eye.

The study will take place over several years, with regular check-ups to assess the effects of the treatment. Participants will be monitored for any side effects, both related to the eye and overall health. The goal is to determine if faricimab can help maintain or improve vision in people with polypoidal choroidal vasculopathy, providing valuable information for future treatments of this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, the first step involves an initial visit to the clinic. During this visit, a healthcare professional will confirm eligibility based on specific criteria, such as age and medical condition.

    A detailed eye examination will be conducted to ensure the eye is suitable for the study. This includes checking for clear ocular media and adequate pupillary dilation to capture good quality retinal images.

  2. Step 2

    Diagnosis confirmation

    The diagnosis of polypoidal choroidal vasculopathy (PCV) will be confirmed using specialized imaging techniques. This involves identifying active macular polypoidal lesions and any exudative or hemorrhagic features affecting the macula.

  3. Step 3

    Baseline assessment

    A baseline assessment of Best Corrected Visual Acuity (BCVA) will be performed. This involves reading letters on a chart from a distance of 4 meters to determine the current level of vision.

  4. Step 4

    Treatment administration

    The treatment involves receiving injections of faricimab, a medication administered directly into the eye through a procedure known as intravitreal injection. The solution used is called Vabysmo 120 mg/mL.

    The frequency and duration of these injections will be determined by the healthcare team based on individual response and study protocol.

  5. Step 5

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor progress and assess the effectiveness of the treatment. These visits will include repeated eye examinations and BCVA assessments.

    The primary goal is to observe any changes in vision and the condition of the eye over time, particularly at weeks 40, 44, or 48.

  6. Step 6

    Final assessment

    At the end of the study, a final assessment will be conducted to evaluate the overall outcomes of the treatment. This includes measuring changes in BCVA and examining the eye for any remaining polypoidal lesions or fluid.

Who can join the trial?

10 criteria

  • Signed informed consent form, which means you agree to participate after understanding the study.
  • Age must be 50 years or older.
  • Must be of Caucasian ethnicity.
  • Must be able to follow the study rules and procedures, as judged by the study doctor.
  • For women who can have children: Must agree to not have heterosexual intercourse or use birth control during the study.
  • For the eye being studied: Must have clear enough eye structures and a wide enough pupil to take good quality pictures of the retina (the back part of the eye) to confirm the diagnosis.
  • Must have a confirmed diagnosis of symptomatic macular polypoidal choroidal vasculopathy (PCV), which is a specific eye condition, as shown by special imaging tests.
  • Must have active macular polypoidal lesions, which are abnormal blood vessel growths in the eye, shown by a test called ICGA (Indocyanine Green Angiography).
  • Must have signs of fluid or bleeding in the macula, the central part of the retina, as identified by the study doctor using various imaging tests.
  • Must have a Best Corrected Visual Acuity (BCVA) score between 78 and 24 letters, which is a measure of how well you can see, using a specific eye chart test.

Who cannot join the trial?

8 criteria

  • Patients with any other eye disease that could affect vision.
  • Patients who have had eye surgery in the last 3 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of stroke or heart attack in the last 6 months.
  • Patients who are pregnant or breastfeeding.
  • Patients with an allergy to the study medication.
  • Patients who are participating in another clinical trial.
  • Patients with any serious illness that could affect their ability to participate.
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Investigated drugs

Faricimab is a medication used in this clinical trial to help improve vision in patients with a specific eye condition called polypoidal choroidal vasculopathy. This condition affects the blood vessels in the eye, leading to vision problems. Faricimab is given as an injection directly into the eye, which is known as an intravitreal injection. The goal of using Faricimab in this study is to see how well it can help improve and maintain the best possible vision for patients with this condition. The study also looks at how safe the medication is for patients and how long its effects last. By participating in this trial, patients may experience improvements in their vision and contribute to research that could help others with similar eye conditions in the future.

What is already known about the treatment

Faricimab – Faricimab is administered through an injection directly into the eye, a method known as intravitreal injection. It is currently being studied in clinical trials for its effectiveness and safety in treating polypoidal choroidal vasculopathy, a condition affecting the blood vessels in the eye. The main goal of using Faricimab is to improve vision in patients with this condition. At the molecular level, Faricimab works by blocking specific proteins that contribute to abnormal blood vessel growth and leakage in the eye. It is classified as an angiogenesis inhibitor, which means it helps prevent the formation of new blood vessels that can cause vision problems.

Investigated diseases

Polypoidal Choroidal Vasculopathy – This disease is characterized by the presence of abnormal blood vessel growth beneath the retina, specifically in the choroid layer. It often leads to the formation of polyp-like structures that can leak fluid or bleed, causing damage to the retinal tissue. As the condition progresses, it can result in visual disturbances such as blurred vision or dark spots in the field of vision. The disease may cause swelling and thickening of the retina due to fluid accumulation. Over time, these changes can lead to a gradual decline in central vision. The condition is more commonly observed in certain populations and can be mistaken for other retinal diseases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515640-22-00Protocol codeECR-AMD-2024-15Estimated enrolment120 patientsSponsorAssociation For Innovation And Biomedical Research On Light And Image

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).