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Study of Faricimab Treatment Given Every 24 Weeks in Patients with Age-Related Macular Degeneration

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on patients with neovascular age-related macular degeneration, a condition where abnormal blood vessels grow in the back of the eye, affecting central vision. The research evaluates a medication called faricimab (also known as RO6867461), which is given as an injection into the eye (intravitreal injection). This medicine works by targeting specific proteins that cause abnormal blood vessel growth in the eye.

The purpose of this study is to determine how well faricimab works and how safe it is when given to patients over extended periods, with treatments spaced up to 24 weeks apart. The medication is provided as a solution for injection with a strength of 120 mg/mL. During the study, participants will receive eye injections according to different schedules, and their vision will be monitored regularly.

The study will track changes in participants' vision and examine the thickness of specific layers in the retina over time. The treatment period lasts for approximately 96 weeks, during which patients will receive regular eye examinations and vision tests. The study will monitor both the benefits of the treatment and any side effects that may occur in the eye or elsewhere in the body.

The research process

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

Step 1
Initial treatment phase
You will receive faricimab (Vabysmo) through an injection into your eye (intravitreal injection).
This treatment is for age-related macular degeneration, a condition that affects your vision.
Step 2
Vision measurements
Your vision will be tested using a special eye chart (ETDRS chart) from a distance of 4 meters.
The medical team will measure the changes in your vision compared to when you started treatment.
Step 3
Eye monitoring
Regular eye scans will be performed to measure the thickness of your central retina.
The medical team will check for any fluid in or under your retina using special imaging equipment.
Step 4
Treatment schedule assessment
Your treatment schedule may be adjusted to one of these intervals: every 4, 8, 12, 16, 20, or 24 weeks.
The schedule will be evaluated at week 52 and week 100 of the study.
Step 5
Long-term monitoring
Your vision will be checked regularly, with special attention at weeks 44, 48, and 52.
Additional important checkpoints will occur at weeks 92, 96, and 100.
The medical team will monitor for any eye-related or general health changes throughout the study.
Step 6
Study duration
The study will continue until January 31, 2028.
Regular appointments will be scheduled throughout this period to monitor your progress.

Who can join the trial?

7 criteria

Must be 50 years or older when signing the consent form
Must be in generally good health, as determined by medical history and physical examination
Must agree to follow the study's contraception requirements
Must have untreated macular neovascularization (new abnormal blood vessel growth in the eye) related to age-related macular degeneration, with fluid present in or under the retina as confirmed by special eye imaging (OCT scan)
Must have specific vision levels measured using a standardized eye chart (ETDRS chart):
- Vision must be between 83 and 24 letters
- This is approximately equal to 20/25 to 20/320 vision
- Must have clear enough eye structures and ability to dilate pupils adequately to allow good quality eye imaging

Who cannot join the trial?

12 criteria

History of active eye inflammation or infection in either eye within 3 months before screening
Previous treatment with anti-VEGF therapy (medication that blocks formation of abnormal blood vessels) in either eye within 3 months
Uncontrolled blood pressure (readings higher than 180/100 mmHg) at screening
History of stroke or heart attack within 6 months before screening
Any eye surgery within 3 months before screening
Presence of other eye conditions that could affect vision such as glaucoma (increased pressure in the eye) or diabetic retinopathy (eye damage due to diabetes)
Pregnant or breastfeeding women
Known allergies to the study medication or similar drugs
Participation in another clinical trial within 3 months before screening
Active or suspected eye or body infections that require treatment
History of blood clotting disorders or current use of blood thinners (except aspirin)
Any condition that, in the opinion of the study doctor, would make participation unsafe

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
Verified
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, Italy
Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy

Trial locations

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Investigated drugs

Faricimab is a medication given by injection into the eye (intravitreal injection) to treat neovascular age-related macular degeneration, which is an eye condition that can cause vision loss. This medication works by targeting and blocking specific proteins that contribute to abnormal blood vessel growth and fluid leakage in the back of the eye. It helps to maintain and potentially improve vision in patients with this condition.

Faricimab

What is already known about the treatment

Faricimab – An innovative bispecific antibody medication administered through intravitreal injection directly into the eye for treating neovascular (wet) age-related macular degeneration. This medication works by simultaneously targeting and inhibiting two distinct pathways (VEGF and angiopoietin-2) involved in blood vessel formation and vascular instability in the retina, making it the first dual-acting treatment in ophthalmology. Faricimab belongs to the class of ophthalmologic antiangiogenic agents and represents a significant advancement in retinal disease treatment, offering the potential for extended dosing intervals of up to 24 weeks between treatments, which may reduce the burden of frequent eye injections for patients.

Investigated diseases

Neovascular Age-Related Macular Degeneration - A progressive eye condition that affects the central part of the retina called the macula. It occurs when abnormal blood vessels grow beneath the retina, leading to fluid leakage and bleeding. The condition primarily affects older adults and causes distortion of central vision while peripheral vision typically remains intact. As the disease progresses, it can result in the formation of scar tissue in the macula, causing blurred or distorted vision when looking straight ahead. The condition typically develops gradually, affecting one eye first, though it can eventually impact both eyes.