Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Two initial faricimab loading doses in treatment-naive neovascular AMD

This research is focused on wet age-related macular degeneration (AMD), an eye condition that can cause blurry vision. The study is investigating a treatment called Vabysmo, delivered as an injection. Specifically, it's a 'Phase IV' study, which means the medicine is already approved, and researchers are now looking at different ways to use it in real-world settings. The main goal is to find out what percentage of patients show no signs of active disease after receiving two initial doses of Vabysmo, checked at week 8. They also want to understand if these initial doses help stretch out the time between future injections and how the treatment affects vision and swelling in the eye. Essentially, they're trying to see if a specific starting plan for Vabysmo can lead to better or more convenient treatment for patients with this eye condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Medical University Of Graz

Enrolment target

Start

14 Oct 2024

Neovascular age-related macular degeneration

What is this study about?

This study is dedicated to understanding more about how to best treat a specific eye condition called neovascular (or 'wet') age-related macular degeneration (AMD). This condition affects the macula, the part of your eye responsible for sharp, central vision. In wet AMD, unwanted new blood vessels grow under the retina, which can leak fluid and blood, leading to blurred vision or blind spots.

The main aim of this research is to explore a particular way of using a medicine called Vabysmo (also known as faricimab). Vabysmo is given as an injection into the eye and is already approved for treating wet AMD. In this study, doctors are giving patients two initial doses of Vabysmo close together at the start of their treatment. They want to see if this 'loading dose' approach helps control the disease more effectively and quickly.

Researchers will closely monitor how patients' eyes respond at 8 weeks after starting treatment to see how many show no signs of active disease. They will also track how long patients can go between subsequent injections, how their vision changes, and if swelling in their eye improves. This information will help doctors understand if this specific starting approach with Vabysmo can lead to better outcomes and potentially fewer injections for people with wet AMD.

Key takeaways

The study is for adults with wet age-related macular degeneration (AMD).
It's exploring a specific starting plan for Vabysmo injections.
The goal is to see if two initial doses help control the disease quickly.
Researchers will monitor vision, eye swelling, and injection frequency.
Participation involves regular eye checks and injections.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There's no upper age limit, meaning older adults are welcome to participate if they meet other criteria.

Both men and women are eligible to join the study. The research is specifically for people who have been diagnosed with 'wet' age-related macular degeneration (AMD), which is a common eye condition.

Importantly, this study is for individuals who have not received treatment for their wet AMD before. This means if you've already had injections or other therapies for this condition, this particular study might not be suitable for you.

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.

Are you 18 years old or older?
Have you been diagnosed with 'wet' age-related macular degeneration (AMD)?
Have you *never* received treatment for your wet AMD before?
Are you able to attend regular clinic appointments for eye injections and checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Vabysmo, as injections into your eye. The study starts with two initial doses given within a short period. Throughout the study, you would have regular appointments at the clinic. These visits would involve eye examinations, including checks of your vision using an eye chart, and special scans of your eye (like OCT and OCTA scans) to look at the back of your eye in detail. Researchers will be especially interested in your progress up to 8 weeks after starting the treatment, but they will follow your eye health for a longer period to see how often you need further injections. The exact total duration of your participation would be explained fully by the study team.

Potential risks and benefits

Participating in any clinical study carries potential benefits and risks. A potential benefit of this study is receiving Vabysmo, a treatment used for wet AMD, potentially with a starting regimen that aims for faster control of the disease. However, as with any eye injection, there are risks such as eye pain, discomfort, blurred vision, infection, or, very rarely, more serious eye problems. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Austria

Common questions

What is 'wet' age-related macular degeneration (AMD)?

Wet AMD is an eye condition where abnormal blood vessels grow under the central part of your retina, called the macula. These vessels can leak, causing vision loss or blurriness.

What is Vabysmo?

Vabysmo is a medicine given by injection into the eye, used to treat wet AMD by helping to control the growth and leakage of these abnormal blood vessels.

What does 'loading doses' mean?

Loading doses refer to giving two initial injections of the medicine within a short timeframe at the very beginning of the treatment. The idea is to achieve a quicker effect.

Will I have different tests if I join this study?

Yes, you will have regular eye exams, including vision checks and special scans of your eye like OCT (Optical Coherence Tomography) and OCTA (Optical Coherence Tomography Angiography), which help doctors see details inside your eye.

Is this medicine new?

Vabysmo (faricimab) is an approved medicine for wet AMD. This study is looking at a specific way of starting treatment with it, rather than testing a completely new, unapproved medicine.