Ongoing Clinical Trials for Polypoidal Choroidal Vasculopathy
Currently, there is one ongoing clinical trial investigating treatment options for polypoidal choroidal vasculopathy, an eye condition characterized by abnormal blood vessel growth beneath the retina. This trial is evaluating the effectiveness and safety of faricimab, a medication administered through eye injections, in improving and maintaining vision for patients with this condition. The study is being conducted across multiple European countries.
Clinical trial locations
- Italy
- Portugal
- Spain
Study on the Effects of Faricimab for Caucasian Patients with Polypoidal Choroidal Vasculopathy
This clinical trial is investigating faricimab as a treatment for polypoidal choroidal vasculopathy, a condition that affects the blood vessels in the eye and can lead to serious vision problems. The study aims to evaluate how well this medication can improve and maintain vision in affected patients.
Who can participate:
To join this study, participants must meet several criteria. They need to be at least 50 years old and of Caucasian ethnicity. The diagnosis of polypoidal choroidal vasculopathy must be confirmed through specialized imaging tests that show active abnormal blood vessel growths in the macula, the central part of the retina. Participants must also have signs of fluid or bleeding in this area. Vision must fall within a specific range, measured between 78 and 24 letters on a standardized eye chart. The eye structures must be clear enough, and the pupil must dilate adequately to allow for high-quality retinal imaging. Women who can have children must agree to use appropriate birth control during the study. All participants must provide signed informed consent and be able to follow the study procedures.
Who cannot participate:
Several conditions exclude people from participating in this trial. Patients with any other eye disease that could affect vision are not eligible. Those who have had eye surgery within the past three months or have uncontrolled high blood pressure cannot join. A history of stroke or heart attack in the last six months is also an exclusion factor. Pregnant or breastfeeding women are not allowed to participate. Anyone with an allergy to the study medication, those currently participating in another clinical trial, or those with any serious illness that could affect their ability to participate will be excluded.
What the study involves:
The trial uses faricimab, also known by its code name RO6867461. This medication is given as an injection directly into the eye, a procedure called intravitreal injection. Faricimab works at the molecular level by blocking specific proteins that contribute to abnormal blood vessel growth and leakage in the eye. It is classified as an angiogenesis inhibitor, meaning it helps prevent the formation of new blood vessels that can cause vision problems.
Participants will undergo an initial visit where their eligibility is confirmed and a detailed eye examination is conducted. After the diagnosis is confirmed through specialized imaging techniques, a baseline vision assessment will be performed using the Best Corrected Visual Acuity test, which involves reading letters on a chart from a distance of four meters. Treatment then begins with regular faricimab injections into the eye. The frequency and duration of these injections are determined by the healthcare team based on individual response and the study protocol.
Throughout the study, participants attend regular follow-up visits to monitor their progress. These visits include repeated eye examinations and vision assessments to observe any changes over time. The primary goal is to track improvements in vision and the condition of the eye, particularly at weeks 40, 44, or 48. At the end of the study, a final assessment evaluates the overall treatment outcomes, including changes in vision and examination of the eye for any remaining abnormal blood vessel growths or fluid.
Study goals:
The main focus of this trial is to determine how effective and safe faricimab is in improving vision for patients with polypoidal choroidal vasculopathy. The study will monitor changes in the ability to see clearly, the presence of fluid in the eye, and changes in the thickness of the retina. By participating, patients may experience improvements in their vision while contributing to research that could benefit others with similar eye conditions in the future.
Summary
Currently, one clinical trial is actively investigating treatment for polypoidal choroidal vasculopathy across three European countries: Portugal, Italy, and Spain. This trial focuses exclusively on faricimab, an angiogenesis inhibitor administered through eye injections. The study specifically targets Caucasian patients aged 50 and older with confirmed disease and active abnormal blood vessel growth in the macula. The research aims to provide valuable information about the effectiveness and safety of faricimab in maintaining or improving vision for people affected by this condition. The trial’s focus on a specific population and single treatment approach reflects a targeted investigation into this particular eye disease.