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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Alm Servicos De Oftalmologia Medica E Cirurgica S.A.	Lisbon	Portugal
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Fundacion De Oftalmologia Medica De La Comunitat Valenciana	Valencia	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Unidade Local De Saude De Loures-Odivelas EPE	Loures	Portugal
Multimedica S.p.A.	Milan	Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia	Rome	Italy
Instituto Oftalmologico Fernandez-Vega S.L.	Oviedo	Spain
Institut Catala De Retina S.L.	Barcelona	Spain
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda.	Coimbra	Portugal
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Uhqfxvrrltwyrmutf Dawdb Sjxbp Dp Ursqf	Udine	Italy
Vbfxel Ofaqnslhdtrih Rzypxsgw Sopi	Sant Cugat Del Valles	Spain
Hzrslpmt Vhxc defhmlel	Barcelona	Spain
Cxiqti Hohhgnkrdw E Uebdmtvwzfxes Di Cslefrn Ecfqgh	Coimbra	Portugal

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.07.2025
Portugal	Recruiting	01.07.2025
Spain	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Faricimab

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.

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 ID:

2024-515640-22-00

Protocol code:

ECR-AMD-2024-15

NCT ID:

NCT06709339

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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