A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)
This research study is investigating a new medication called EYE201 (also known as MK-8748) for people with 'wet' age-related macular degeneration, often shortened to NVAMD. This condition affects your central vision. The study aims to find out how safe and effective EYE201 is when given by injection into the eye, comparing it directly with a widely used treatment called aflibercept. Participants will receive either the new medicine or the existing one, and their vision will be regularly checked. The main goal is to see if EYE201 can improve or protect eyesight over the course of a year. This type of study helps doctors understand if new treatments could be better options for patients in the future.
At a glance
What is this study about?
This study is designed to learn more about a new treatment, EYE201, for a eye condition called 'wet' age-related macular degeneration (NVAMD). NVAMD happens when abnormal blood vessels grow underneath the macula, which is the part of your eye responsible for sharp, central vision. These vessels can leak blood and fluid, damaging your vision. Without treatment, NVAMD can lead to significant vision loss.
The study will compare EYE201 with an existing and commonly used treatment called aflibercept. Both medications are given as injections directly into the eye. Researchers want to see if EYE201 is as good as, or even better than, aflibercept at improving or keeping people's vision stable. They'll also carefully look at any side effects to make sure EYE201 is safe.
The main way the study will measure success is by checking changes in vision, specifically how many letters people can read on an eye chart, over a year. The results from this study will help determine if EYE201 could become a new option for treating NVAMD in the future, potentially offering more choices for patients in the UK.
Key takeaways
- This study evaluates a new treatment (EYE201) for 'wet' age-related macular degeneration.
- It compares EYE201 to an established treatment (aflibercept).
- The main aim is to see if EYE201 is safe and helps improve or maintain vision.
- Participation involves regular clinic visits and eye injections over about a year.
- Both men and women, aged 18 and over, with NVAMD, can be considered.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate. The study is specifically for people who have been diagnosed with 'wet' age-related macular degeneration (NVAMD).
There might be other specific health requirements or conditions that would mean you can or cannot join. For example, some people might not be able to take part if they have certain other eye conditions or if they are already receiving specific treatments for their NVAMD.
It's important to remember that not everyone with NVAMD will be able to join. The research team will review your medical history and conduct several tests to make sure the study is a good fit for you and that taking part would be safe.
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 (NVAMD)?
- Are you open to receiving injections in your eye?
- Can you commit to attending regular clinic appointments for about a year?
What does participation involve?
If you decide to join this study, you'll be assigned by chance (like flipping a coin) to receive either the new medicine (EYE201) or the existing treatment (aflibercept). You, and in many cases your doctors, won't know which treatment you are getting. Both medicines are given as injections into the eye.
You will need to attend regular visits to the clinic over a period of time, likely at least a year. These visits will involve various tests, such as eye exams, vision checks using an eye chart, and possibly other scans or pictures of your eye. These assessments help the doctors monitor your eye condition and see how the treatment is working. You will also have follow-up appointments after the main treatment period to ensure your safety and monitor your long-term vision.
Potential risks and benefits
Locations (8)
- —UnverifiedAustria
- —UnverifiedSlovakia
- —UnverifiedPortugal
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedDenmark
- —UnverifiedItaly
Common questions
What is 'wet' age-related macular degeneration (NVAMD)?
It's an eye condition where new, leaky blood vessels grow under the macula, affecting your sharp central vision.
What is EYE201?
EYE201 is a new medication being tested to treat 'wet' age-related macular degeneration.
What is aflibercept?
Aflibercept is an existing and commonly used medication for treating 'wet' age-related macular degeneration.
How will I know if the treatment is working?
Your vision will be regularly checked using eye charts and other tests to see if your eyesight improves or stays stable.
Will I know if I'm getting the new medicine or the old one?
This is a 'masked' study, meaning neither you nor your doctors will usually know which of the two treatments you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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