CompletedObservational

An observational study to understand markers indicating disease progression in dry age-related macular degeneration

This study is for people with intermediate age-related macular degeneration (iAMD) or geographic atrophy (GA), which are common eye conditions that can affect your central vision. We want to understand how these conditions change over time. By observing changes in the eye using special scans and tests, we hope to find early indicators of disease progression. This information could eventually help develop better ways to monitor and treat AMD in the future. If you're aged 50-90 and have iAMD or GA, you might be able to take part. The study involves a year of eye exams and scans at Moorfields Eye Hospital, with visits at the start, 3, 6, and 12 months.

At a glance

Status

Completed

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Enrolment target

200

Start

30 Oct 2023

Estimated completion

31 Jan 2025

What is this study about?

This study is called PROBE-IGA, which stands for "A Prospective, Observational study for identification of biomarkers of disease progression in Intermediate Age related Macular Degeneration and Geographic Atrophy." It's an observational study, which means we will be carefully watching and recording changes in your eyes over time, rather than testing a new medicine or treatment.

The main goal of this study is to better understand dry age-related macular degeneration (AMD), especially what we call 'intermediate AMD' and 'geographic atrophy' (GA). These are common eye conditions that can cause central vision loss. We want to find early warning signs or 'markers' that tell us when these conditions might be getting worse. By identifying these markers, we hope to improve how doctors understand and track the disease.

We plan to follow participants for one year. During this time, we'll collect information from various eye tests and scans. The hope is that the information we gather will help scientists and doctors develop better ways to diagnose, monitor, and potentially treat AMD in the future. While this study won't offer a direct benefit to participants now, it's a vital step in advancing our knowledge and potentially helping people with AMD in years to come.

Key takeaways

This is an observational study of dry AMD (intermediate AMD and geographic atrophy).
It aims to find early signs of disease progression over one year.
Participation involves four visits to Moorfields Eye Hospital for eye exams and scans.
There are no treatments or medications given as part of this study.
Your contribution will help advance understanding of AMD for future patients.
The study runs from October 2023 to October 2025.

Who may be eligible?

This study is looking for both men and women between 50 and 90 years old who have either intermediate age-related macular degeneration (iAMD) or geographic atrophy (GA) in at least one eye.

For those with iAMD, your vision in at least one eye needs to be reasonably good (6/18 or better on an eye chart), and your eye needs to be clear enough for us to take good quality pictures and perform all the required tests.

For those with GA, you just need to have a diagnosis of GA in at least one eye, whether it's in the very centre of your vision or slightly to the side. Your eye also needs to be clear enough for our imaging tests. Unfortunately, if you have other serious eye conditions that could affect your vision, have had major eye surgery recently, or have received certain eye treatments, you might not be able to join. We also can't include people who have participated in certain other clinical trials for GA or early AMD, although taking vitamins and minerals is fine.

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 50 and 90 years old?
Have you been diagnosed with intermediate AMD or geographic atrophy (GA) in at least one eye?
Is your vision good enough (6/18 or better) if you have intermediate AMD?
Do you have a clear view into your eye for scans and tests?
Have you *not* had major eye surgery or certain eye treatments recently?
Have you *not* participated in certain other clinical trials for GA or early AMD (unless it was for vitamins/minerals)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be observed for a period of one year. This means you will have a total of four visits to Moorfields Eye Hospital in London: one at the very start (this is called your baseline visit), and then follow-up visits after 3 months, 6 months, and 12 months. Each visit will involve several assessments.

At each visit, we will ask about your general health and eye history. You'll have your vision checked in detail and a thorough examination of your eyes. You'll also have a range of special eye scans, such as SD-OCT, OCTA, NIR, FAF, colour photographs, and EDI-OCT. These scans are non-invasive and help us see different layers and details of your eye.

In addition to these scans, at your first visit, and then again at the 6-month and 12-month visits, you'll have two extra tests for your vision function: one called dark adaptation (DA) and another called microperimetry (MP). These tests help us understand how your eyes adapt to different light levels and how sensitive your central vision is. There are no medications or treatments involved, as this is purely an observational study where we gather information.

Potential risks and benefits

There will be no direct medical benefit to you from taking part in this study. However, by participating, you will be contributing vital information that could help scientists and doctors better understand how dry age-related macular degeneration (AMD) progresses. This improved understanding may lead to better ways to manage and treat AMD for future patients. The study primarily involves eye examinations and scans, which are generally safe and commonly performed. The main risks are minor discomfort from bright lights during eye exams or from eye drops if they are needed to widen your pupils. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

NIHR Moorfields Clinical Research Facility
City only
London, United Kingdom

Common questions

What is dry age-related macular degeneration (AMD)?

It's a common eye condition that affects the macula, the central part of your retina, leading to blurry or distorted central vision. Dry AMD tends to progress slowly.

What is geographic atrophy (GA)?

Geographic atrophy (GA) is an advanced form of dry AMD where patches of light-sensing cells in the macula have wasted away, causing blind spots in central vision.

Will I receive treatment in this study?

No, this is an observational study. You will not receive any treatment. We are only observing and collecting information about how your eye condition changes over time.

How long will the study last and how many visits are there?

The study will last for one year, with a total of four visits: one at the start, and then at 3 months, 6 months, and 12 months.

Where is the study taking place?

The study is being run from Moorfields Eye Hospital’s Clinical Research Facility in London, UK.

How to find out more

Rabiah Abbas Saud

rabiah.abbassaud@nhs.net +44 (0)207 5662285 Official trial record

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