RecruitingOBSERVATIONAL

Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

This study is for people with a specific type of age-related macular degeneration (AMD) that currently doesn't affect their central vision. Doctors want to understand how this condition changes over two years, focusing on parts of the eye that aren't yet causing central vision problems. They'll use advanced eye scans and special computer programs (AI) to track these changes closely. The main goal is to learn how quickly the condition might progress in each person and to develop better ways to monitor it in the future. Participants will have regular eye check-ups, including scans, over two years. There won't be any new treatments given as part of this study.

At a glance

Status

Recruiting

Sponsor

Medical University of Vienna

Enrolment target

200

Start

11 Apr 2025

Estimated completion

01 Jul 2027

What is this study about?

This study is looking into a specific type of Age-Related Macular Degeneration (AMD) called atrophic AMD. This particular type affects the outer parts of your retina, rather than the very centre (which is called the fovea). Importantly, for participants in this study, this condition isn't currently compromising their central vision, so they aren't experiencing significant vision loss from it yet.

The main aim is to understand how this particular form of AMD progresses over time in individual people. Researchers want to use advanced imaging techniques and special computer programs, known as Artificial Intelligence (AI), to track subtle changes in the eye. By doing this, they hope to predict how quickly the condition might advance and to develop a more personalised way to monitor patients in the future. This could eventually lead to better ways to detect progression early and, when treatments become available, to know who might benefit most.

Over two years, participants will have regular check-ups where doctors will take detailed pictures and scans of their eyes. They’ll also ask about medical history and vision. There are no new medications or treatments given as part of this study, as there isn't an approved treatment for this specific type of AMD in Europe yet. If a treatment becomes available during the study, participants might receive it, but this would happen outside the study’s main activities.

Key takeaways

This study observes a specific type of AMD that doesn't yet affect central vision.
It uses advanced eye scans and AI to track changes over two years.
Participation involves regular eye check-ups every six months, but no new treatments are given.
The goal is to better understand disease progression and improve future monitoring for patients.
It lasts for two years and involves several types of eye imaging tests.

Who may be eligible?

This study is looking for people generally aged between 55 and 99 years old. A key requirement is that you have a specific type of AMD where certain layers of your retina show signs of atrophy (thinning or wear), particularly in areas that are not affecting your main, central vision yet. The eye doctor will be able to confirm if you meet these specific criteria using eye scans.

You also need to have healthy eyes otherwise, meaning good, clear vision for the eye scans to work properly. If both of your eyes meet the study requirements, both can be included, which is quite unique.

There are also some reasons why you might not be able to join. For example, if you've had recent eye surgery (within the last three months), or a history of certain eye treatments or conditions like uncontrolled glaucoma or severe cataracts. Also, if you're taking certain medications that can affect the retina, or have other active eye conditions like wet AMD, you wouldn't be able to take part.

Quick self-check

Are you between 55 and 99 years old?
Do you have diagnosis of atrophic AMD that is NOT yet affecting your central vision?
Is your vision clear enough for eye scans?
Have you avoided eye surgery in the last 3 months?
Do you have no other serious, uncontrolled eye conditions like severe glaucoma or advanced cataracts?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be followed for a full two years. During this time, you'll have appointments every six months. At each visit, the study team will ask about your medical history and a questionnaire about your vision. You will also have a standard eye exam. A key part of your participation will involve several advanced eye scans and photographs, which include different types of scanning laser fundus photography and Optical Coherence Tomography (OCT). These special scans help doctors see detailed layers of your retina and blood vessels.

It's important to know that no new treatments or medications will be given as part of this study, as no specific treatment is currently available in Europe for this type of AMD. However, if a treatment becomes approved for this condition during the study, you might be able to start it under the guidance of your own doctor, outside of the study’s main focus.

Potential risks and benefits

Taking part in this study won't offer a direct benefit or treatment for your AMD right now, as it's an observational study. However, it will provide very detailed monitoring of your eye condition over two years, potentially helping you and your doctor understand its progression better. The information gathered may also help future patients by leading to better understanding and monitoring of this type of AMD. The main risks involve the procedures like eye scans, which are generally safe routine exams, but may involve bright lights or pupil dilation that can temporarily blur vision. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (7)

Medical University of Vienna
Vienna, Austria· Not yet recruiting
CHU Dijon
Dijon, France· Recruiting
University Medical Center Ljubljana
Ljubljana, Slovenia· Recruiting
Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed
Barcelona, Spain· Recruiting
Vista Klinik Binningen
Binningen, Switzerland· Recruiting
University of Zürich
Zurich, Switzerland· Recruiting
Queen's Unviversity Belfast
Belfast, United Kingdom· Recruiting

Common questions

What kind of AMD is this study for?

It's for a specific type of Age-Related Macular Degeneration (AMD) that currently doesn't affect your central clear vision.

Will I get any treatment in this study?

No, this study doesn't involve new treatments. It's about observing how the condition changes over time using eye scans.

How long will I be in the study?

You'll be followed for two years, with eye check-ups and scans every six months.

What are the eye scans like?

The scans are routine eye tests like OCT and special photographs. They are usually quick and painless, but may involve bright lights.

Can both my eyes be included?

Yes, if both your eyes meet the specific study requirements, both can be part of the study.

How to find out more

Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc

gregor.reiter@meduniwien.ac.at +43 1 40400-73419 Official trial record

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