Active not recruitingOBSERVATIONAL

Development of Novel Clinical Endpoints in Intermediate AMD

This research project, called MACUSTAR, is focused on understanding and better measuring intermediate Age-related Macular Degeneration (AMD). The main goal is to find improved ways to track the condition's progression for future treatments and to help patients. The study will look at how vision changes, how the eye structure changes, and how people with AMD feel about their vision. Researchers also want to find out what puts people at higher risk of their AMD getting worse. This study does not involve new medications or treatments; instead, it observes people with different stages of AMD to learn more about the condition itself. Your participation would help doctors better understand and manage AMD in the future.

At a glance

Status

Active not recruiting

Sponsor

Frank G. Holz

Enrolment target

718

Start

26 Mar 2018

Estimated completion

28 Feb 2026

Age Related Macular Degeneration (AMD)

What is this study about?

This study is called MACUSTAR and it's all about Age-related Macular Degeneration (AMD), specifically the 'intermediate' stage. AMD is an eye condition that affects your central vision. Often, when studies look at new treatments, they need good ways to show if the treatment is working. This study isn't testing a new treatment; instead, it's trying to find the best ways to measure changes in people with intermediate AMD.

The researchers want to figure out the best tests and measurements to use in future studies to see if treatments are effective. They'll be looking at things like how well people can see, detailed pictures of the back of the eye, and how patients themselves feel about their vision. They also want to understand what makes AMD get worse and what puts someone at higher risk of moving from intermediate AMD to more advanced forms.

The information gathered from this study will help ensure that future clinical trials testing new AMD treatments can more accurately measure their success. This will ultimately help get new, effective treatments to patients faster and ensure they are approved by health regulators.

Key takeaways

This study helps understand Age-related Macular Degeneration (AMD) better.
It aims to find new ways to measure AMD changes for future treatment studies.
No new treatments or medications are given in this study.
Participation involves eye exams and questionnaires.
Your contribution could help many people with AMD in the future.

Who may be eligible?

To join this study, you generally need to be between 55 and 85 years old. You must be able and willing to give written permission to take part and attend all the required appointments and tests.

Specific conditions for joining depend on whether you have no AMD, early AMD, intermediate AMD, or advanced AMD. For example, if you have intermediate AMD, both of your eyes need to have this condition or advanced AMD in one eye, as long as it's not affecting the very centre of your vision. Your vision in the study eye also needs to be at a certain level. There are other groups for people with early AMD, with more advanced AMD, or even people with no AMD at all.

You would not be able to join if you have other eye problems like severe cataracts or glaucoma that might interfere with the study. Also, if you have severe diabetic eye disease or certain other macular diseases, you wouldn't be suitable. Your eye doctor would check all these details carefully to 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 between 55 and 85 years old?
Are you able and willing to attend all study appointments and tests?
Do you have no AMD, early AMD, intermediate AMD, or advanced AMD?
Do you have good enough vision to take part in the tests?
Do you have any other severe eye conditions like bad glaucoma or severe diabetic eye problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't be given any new medication or treatment. Instead, you'll have regular appointments where doctors will perform various eye tests. These tests include checking your vision, taking detailed images of the back of your eye, and asking you questions about your vision. This helps them understand how your AMD might be changing over time and how it affects your daily life. The study involves different parts, including an initial detailed check-up and then follow-up visits to see how things progress. The total duration of your participation will be explained by the study team.

Potential risks and benefits

Participating in this study might not offer any direct benefits to you personally, as it's not testing a new treatment. However, your involvement will greatly help researchers understand AMD better, which could lead to better ways of managing the condition and finding new treatments for others in the future. The risks involved are generally low, mainly related to the time commitment for appointments and routine eye tests, which might involve bright lights or drops that temporarily blur your vision. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

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

Righospitalet Copenhagen
Verified postcode
Copenhagen, Denmark
Centre Hospitalier Intercommunal de Creteil
Verified postcode
Créteil, France
Centre d'Investigation Clinique Centre National d'Ophtalmologie des Quinze-Vingts
Verified postcode
Paris, France
University Hospital Bonn
Verified postcode
Bonn, Germany
University Hospital Cologne
Verified postcode
Cologne, Germany
Department of Ophthalmology, University of Freiburg
Verified postcode
Freiburg im Breisgau, Germany
University Eye Hospital Munich
Verified postcode
Munich, Germany
St. Franziskus Hospital
Verified postcode
Münster, Germany
Universtiy Hospital Tuebingen
Verified postcode
Tübingen, Germany
University Eye Hospital Ulm
Verified postcode
Ulm, Germany
Luigi Sacco Hospital
Verified postcode
Milan, Italy
Ospedale San Raffaele
Verified postcode
Milan, Italy

Common questions

What is the main goal of this study?

The main goal is to find better ways to measure changes in intermediate AMD for future research and patient care.

Will I receive any new treatments or medicines?

No, this study does not involve any new treatments or medications. It's purely observational.

How long will I need to be in the study?

The exact duration will be explained by the study team, as it involves an initial assessment followed by follow-up visits.

Who can participate in this study?

People aged 55-85 with no AMD, early AMD, intermediate AMD, or advanced AMD who meet specific health and vision criteria.

What kind of tests will I have?

You'll have eye tests to check your vision, detailed scans of your eye, and answer questionnaires about your vision and daily life.