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RecruitingPHASE2, PHASE3INTERVENTIONAL

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)

Researchers are exploring new ways to treat wet macular degeneration, a serious eye condition that can affect your vision. Sometimes, current treatments like aflibercept don’t work for everyone. This study aims to find out if a new trial medicine called tiespectus (also known as MK-8748 or EYE201) can be an effective alternative. They want to compare how well tiespectus works against aflibercept. If you've recently been diagnosed with wet macular degeneration and haven't started treatment yet, you might be able to take part. The goal is to provide more options for people living with this condition, helping them maintain their eyesight.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
EyeBiotech Ltd.
Enrolment target
960
Start
27 Mar 2026
Estimated completion
30 Jun 2028

What is this study about?

This study is about a common eye condition called macular degeneration, specifically the 'wet' type (also known as neovascular age-related macular degeneration or NVAMD). This condition affects the central part of your vision, which is important for things like reading and recognising faces. It happens when abnormal blood vessels grow under the macula, leaking fluid and damaging your vision.

Currently, there are good treatments available, such as a medicine called aflibercept. However, these treatments don't always work for every person, or they might not be suitable for everyone. That's why doctors and scientists are constantly looking for new and improved ways to help people with wet macular degeneration. This particular study is investigating a new medicine called tiespectus (you might also hear it called MK-8748 or EYE201).

The main aim of this study is to compare tiespectus with aflibercept. Researchers want to see if tiespectus is just as good, or perhaps even better, at treating wet macular degeneration. By doing this, they hope to offer more options and better outcomes for people living with this condition in the future.

Key takeaways

  • This study is comparing a new eye medicine (tiespectus) with a standard one (aflibercept).
  • It's for people recently diagnosed with 'wet' macular degeneration who haven't had treatment yet.
  • Participation involves regular clinic visits and eye injections.
  • You will receive either the new medicine or the standard treatment, decided randomly.
  • The aim is to find better treatment options for this potentially sight-threatening condition.

Who may be eligible?

To join this study, you generally need to be an adult aged 50 or older. You must have been diagnosed with wet macular degeneration very recently, within the last three weeks, and you shouldn't have received any previous treatment for it in the eye being studied. The study is open to both men and women.

There are also some reasons why you might not be able to join. For example, if you have very high blood pressure that isn't under control, you might not be suitable. Similarly, if you've had certain eye surgeries or treatments in the past few months, like some types of laser treatment, or if you have other ongoing, active eye conditions besides your macular degeneration, you might not be able to take part.

It's important to remember that these are just some of the main points. The medical team will check all your health details carefully to make sure the study is safe and 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.

  1. Are you 50 years old or older?
  2. Have you been diagnosed with 'wet' macular degeneration in the last 3 weeks?
  3. Have you never received treatment for wet macular degeneration in the affected eye?
  4. Do you have well-controlled blood pressure?
  5. Have you avoided certain eye surgeries or laser treatments in the past 3 months in the affected eye?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have regular visits to the clinic. Over the course of the study, you'll receive either the new medicine, tiespectus, or the standard medicine, aflibercept. You won't get to choose which one you receive; it will be decided randomly, like flipping a coin. Both medicines are given as an injection into the eye, and you'll have various eye examinations and tests at each visit to check your vision and how your eye is responding.

The study involves a number of clinic visits over an extended period. The exact number and frequency of visits will be explained in detail by the study staff. You'll have thorough eye check-ups, including special scans and vision tests. There will also be general health checks to make sure you are well throughout the study. The total duration of your participation in the study, from your first visit to your final follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as receiving close medical attention and access to a new treatment that might improve your condition. However, there are also potential risks involved. The new medicine, tiespectus, is still being studied, so its full effects and side effects are not yet completely known. You might experience side effects from the injections, or the treatment might not work for you. The existing treatment, aflibercept, also has known side effects, which will be explained. Before you agree to take part, the study team will explain all the known and potential risks and benefits in detail. Remember, you can also change your mind and withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (71)

  • Research Network Arizona / Retina Macula Institute of Arizona
    Verified postcode
    Scottsdale, United States· Recruiting
  • Retina Partners of Northwest Arkansas, PLLC
    Verified postcode
    Springdale, United States· Recruiting
  • Global Research Management, Inc.
    Verified postcode
    Glendale, United States· Recruiting
  • Retinal Consultants Medical Group (Site 024)
    Verified postcode
    Modesto, United States· Recruiting
  • Retina Consultants of Southern California (Site 043)
    Verified postcode
    Redlands, United States· Recruiting
  • Retinal Consultants Medical Group (Site 020)
    Verified postcode
    Sacramento, United States· Recruiting
  • Retinal Consultants Medical Group (Site 022)
    Verified postcode
    Sacramento, United States· Recruiting
  • Florida Eye Clinic (Site 130)
    Verified postcode
    Altamonte Springs, United States· Recruiting
  • Retina Group of Florida (Site 070)
    Verified postcode
    Fort Lauderdale, United States· Recruiting
  • Vitreo Retinal Associates
    Verified postcode
    Gainesville, United States· Recruiting
  • Fort Lauderdale Eye Institute (Site 042)
    Verified postcode
    Plantation, United States· Recruiting
  • Retina Vitreous Associates of Florida (Site 049)
    Verified postcode
    St. Petersburg, United States· Recruiting

Common questions

What is 'wet macular degeneration'?

It's an eye condition where abnormal blood vessels grow under the central part of your retina, called the macula, causing fluid leakage and affecting your central vision.

What is the new medicine, tiespectus?

Tiespectus is a trial medicine that researchers are investigating as a potential treatment for wet macular degeneration. It's also known as MK-8748 or EYE201.

Will I definitely get the new medicine if I join?

Not necessarily. Participants will be randomly assigned to receive either the new medicine (tiespectus) or a standard treatment (aflibercept), like drawing lots.

How is the medicine given?

Both the trial medicine and the standard treatment are given as injections directly into the eye.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Toll Free Number

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Trial of EYE201/MK-8748 in People With Macular De…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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