AuthorisedPhase II and Phase III (Integrated)Interventional

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 for people with a common eye condition called wet age-related macular degeneration, or wet AMD. This condition can cause blurry vision and even vision loss if not treated. The study is testing a new medicine called EYE201, which is given as an injection into the eye, and comparing it to a standard treatment called aflibercept. Researchers want to find out if EYE201 is safe and if it can improve people's eyesight as much, or more than, the current treatment over a year. The main way they'll measure this is by checking how many letters people can read on an eye chart.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Eyebiotech Limited

Enrolment target

Start

03 Jun 2026

Neovascular age-related macular degeneration (NVAMD)

What is this study about?

This study is a special kind of research designed to test new medicines or treatments for people. It's looking at a condition called neovascular age-related macular degeneration, often called wet AMD. Wet AMD affects the central part of your vision and can make it hard to see fine details, read, or recognise faces. It happens when abnormal blood vessels grow under the retina (the light-sensitive tissue at the back of your eye) and leak fluid or blood, which damages your vision.

The study aims to see if a new treatment, EYE201, is effective and safe compared to a treatment already approved and widely used, called aflibercept. Both treatments involve injections into the eye. By comparing a new treatment to an existing one, doctors can find out if the new treatment offers benefits, like better vision, fewer side effects, or less frequent injections.

Researchers will be carefully checking how much people's vision improves by looking at changes in their eyesight over a year. They will use a standard eye chart, similar to those used by opticians, to measure how many letters participants can read. This helps them understand if the treatments are working.

Key takeaways

Tests a new eye treatment (EYE201) for wet AMD.
Compares EYE201 to an existing treatment (aflibercept).
Aims to improve vision in people with wet AMD.
Participation involves regular eye injections and check-ups for one year.
You won't know which treatment you receive; your care will be closely monitored.

Who may be eligible?

To join this study, participants must be at least 18 years old. There are no upper age limits, so adults of any age can be considered. The study is open to both men and women.

Beyond these basic requirements, the specific details of a participant's wet AMD will be carefully checked. This includes things like how long they've had the condition and its current state. These checks help make sure the study includes people who are most likely to benefit and for whom the results will be meaningful.

Before you can take part, a doctor on the study team will need to do a full health check and review your medical history. They will explain all the requirements and make sure the study is right 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?
Do you have wet age-related macular degeneration (wet AMD)?
Are you able to attend regular clinic appointments for one year?
Have you discussed this study with your eye doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive regular eye injections with either the new medicine (EYE201) or the standard treatment (aflibercept). You wouldn't know which one you are receiving, and neither would your study doctor, as this helps make the results fairer. You would have regular visits to the study clinic over a year to have your injections and your eyesight checked, which involves reading letters on an eye chart. There will also be other eye exams and general health checks. The study team will explain the exact schedule of visits and what each visit involves. You will be closely monitored throughout your participation.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving expert medical care and access to a new treatment that isn't widely available yet. However, there are also potential risks, including side effects from the injections or the treatments, which will be fully explained by the study team. Like any medical procedure, eye injections carry a small risk of discomfort, infection, or other eye problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Latvia

Common questions

What is wet AMD?

Wet AMD is an eye condition that can cause blurry vision or blind spots. It happens when abnormal blood vessels grow under the central part of your retina and leak fluid or blood, damaging your eyesight.

What is EYE201?

EYE201 is a new medicine being tested in this study for wet AMD. It is given as an injection into the eye, similar to current treatments.

Will I know if I'm getting the new treatment or the standard one?

No, neither you nor your study doctor will know which treatment you are receiving. This is a common practice in research studies to ensure fair results.

How long will I be in the study?

You will take part in the study for about one year, with regular visits to the clinic for treatments and check-ups.

What is measured to see if the treatment works?

Doctors will mainly measure your vision by checking how many letters you can read on a standard eye chart over time.