Active not recruitingPHASE4INTERVENTIONAL

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

This study is investigating a treatment called faricimab for 'wet' Age-related Macular Degeneration (nAMD), a common eye condition that can lead to blurred vision. Researchers want to understand how effective faricimab is at improving or maintaining vision, how safe it is for patients, and how long its effects last. The study will look at giving faricimab injections into the eye at longer intervals, up to every 24 weeks, for people who haven't had previous treatment for their nAMD. It's a large, long-term study that will involve many medical centres and last for 100 weeks (nearly two years).

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Hoffmann-La Roche

Enrolment target

274

Start

14 Mar 2025

Estimated completion

16 Sep 2027

Neovascular Age-related Macular Degeneration (nAMD)

What is this study about?

This research study is about a treatment called faricimab for a specific eye condition known as 'wet' Age-related Macular Degeneration (nAMD). This condition causes blurred vision or blind spots because abnormal blood vessels grow at the back of the eye and leak fluid. Faricimab is a medicine designed to stop these leaks, helping to protect or improve your eyesight.

The main goals of this study are to see how well faricimab works (its 'efficacy') for people newly diagnosed with nAMD, how safe it is to use, and how long its benefits last (its 'durability'). An important aspect of this study is exploring if faricimab can be given less frequently, specifically up to every 24 weeks (about every six months), which could mean fewer clinic visits and injections for patients compared to current treatments.

This is a 'Phase IIIb/IV' study, which means it builds on earlier research that showed faricimab is promising. It's a large-scale study involving many different hospitals or clinics (multicenter). For 100 weeks (nearly two years), researchers will carefully follow participants to gather detailed information about the treatment's effects. The study will help doctors understand the best way to use faricimab to help people with nAMD.

Key takeaways

Investigating a new treatment (faricimab) for 'wet' Age-related Macular Degeneration (nAMD).
Aims to assess efficacy, safety, and how long benefits last with less frequent injections.
Specifically for people newly diagnosed with nAMD who haven't had prior treatment.
The study lasts for 100 weeks (nearly two years).
Involves regular eye check-ups and injections into the eye.
Participation is voluntary, with the right to withdraw at any time.

Who may be eligible?

To join this study, participants generally need to be in good health. Your doctor will carry out medical checks to make sure you're suitable. You'll also need to agree to use contraception methods described in the study rules if they apply to you.

Key requirements for the eye being studied include having 'wet' Age-related Macular Degeneration (nAMD) for the first time – meaning you haven't received previous treatment for it. Your doctor will confirm this based on scans of your eye. Your vision in the study eye also needs to be within a certain range (between 20/25 and 20/320 on a standard eye chart).

There are reasons you might not be able to join. For example, if your nAMD is caused by something other than age-related issues, or if you have certain other eye problems like bleeding in the eye or a history of eye inflammation. If you've previously had injections or treatments for other retinal conditions in the study eye, you generally won't be able to participate. Also, if your other eye (the non-study eye) has very poor vision or is not present, you might not be eligible.

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.

Am I generally in good health?
Do I have 'wet' Age-related Macular Degeneration (nAMD) in one eye that hasn't been treated before?
Is my vision in the affected eye within a certain range (not too good, not too poor)?
Do I have any other significant eye conditions like bleeding or inflammation that might exclude me?
Have I had any previous injections or treatments in the eye being studied for other retinal diseases?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for 100 weeks, which is almost two years. You'll receive injections of faricimab into your study eye. The aim is to see if these injections can be given as infrequently as every 24 weeks (about every six months), but the exact schedule might vary depending on your individual response. Throughout the study, you'll have regular visits to the clinic for eye exams, vision tests, and scans of your eye to monitor your condition and how you're responding to the treatment. These visits will help doctors assess the effectiveness and safety of faricimab. All procedures and examinations will be clearly explained to you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment for your 'wet' AMD that could help maintain or improve your vision. You will also be closely monitored by medical professionals throughout the study. However, like all medical treatments, there are potential risks, including side effects from the medication or the eye injection procedure itself. These will be fully explained to you before you decide to take part. Remember, joining a clinical study is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Orange County Retina Medical Group
Verified postcode
Santa Ana, United States
Florida Retina Institute
Verified postcode
Orlando, United States
Ctr for Retina & Macular Dis
Verified postcode
Winter Haven, United States
Retinal Vitreal Consultants
Verified postcode
Chicago, United States
University Retina and Macula Associates, PC
Verified postcode
Lemont, United States
New England Retina Consultants
Verified postcode
Springfield, United States
Sierra Eye Associates
Verified postcode
Sparks, United States
Retina Associates of New Jersey
Verified postcode
Teaneck, United States
Vision Research Center at Eye Associates of New Mexico
Verified postcode
Albuquerque, United States
Charles Retina Institute
Verified postcode
Germantown, United States
Retina Consultants of Texas
Verified postcode
Schertz, United States
Strathfield Retina Clinic
Verified postcode
Strathfield, Australia

Common questions

What is 'wet' Age-related Macular Degeneration (nAMD)?

It's an eye condition where abnormal blood vessels grow and leak fluid under the macula, the part of your eye responsible for sharp, central vision. This can cause blurred vision or blind spots.

What is faricimab?

Faricimab is a new medicine designed to stop the abnormal blood vessels from leaking, aiming to protect and potentially improve your vision in people with 'wet' AMD.

How is the treatment given?

Faricimab is given as an injection directly into the eye (an intravitreal injection) by an eye specialist.

How long will the study last?

The study is planned to last for 100 weeks, which is nearly two years.

Can I still participate if I've had previous eye injections for my AMD?

Generally, no. This study is for people who haven't had previous treatment for their 'wet' AMD in the eye being studied.