A study looking at the accuracy of using optical coherence tomography angiography at diagnosing an eye condition called neovascular age-related macular degeneration to see if it is just as good as fluorescein angiography

Plain English summary of protocol

Background and study aims
This is a research study looking at the best way to confirm the presence of an eye condition known as neovascular age-related macular degeneration (nAMD), a common condition that affects the middle part of people's vision. The researchers are especially interested in understanding the best way to look at the back of the eye to get a definite diagnosis.
Neovascular age-related macular degeneration (nAMD) is a common condition that affects the middle part of people's vision. It usually first affects people in their 50s and 60s and diagnosis is usually confirmed by looking at the back of the eye. There are a number of ways of doing this, the most common being a test known as Fluorescein Angiography (FA). FA is labour-intensive, time-consuming and inconvenient for the patient and is not always informative meaning that sometimes another dye test called Indocyanine-Green Angiography (ICGA) is needed.
Newer diagnosis tests are now available. One is called Optical Coherence Tomography (OCT) that quickly scans the back of the eye. The findings of OCT can be confused with other conditions and so to get a definite diagnosis of nAMD it is often used alongside other tests such as FA/ICGA.
Optical Coherence Tomography-Angiography (OCTA) is a more recent technology already available in many NHS Trusts. OCTA is non-invasive and provides a better image of the retina and the blood flow to the back of the eye. This study will see if OCTA is a good enough test to replace FA

Who can participate?
People presenting to secondary care whose treating doctors feel that they may have nAMD in at least one of their eyes after an OCT scan

What does the study involve?
Patients are asked to have two further tests; an OCTA and FA. If the patient decides not to take part in the study then it is likely that they will have at least one of these other tests to confirm their diagnosis.
The researchers will ask the eye specialists who are looking after the patient to look at the tests and decide whether there is nAMD and how confident they are of this diagnosis. In half of the cases, chosen by chance, the eye specialists will base their diagnosis on OCT and OCTA and in the other half on OCT and FA. The researchers will compare the results of both combinations of tests to see if they are both equally as good for detecting nAMD.
If the patient does decide to take part, and gives their permission, the treating site will produce an anonymised export of each scan, then pseudo-anonymise with a trial number. These images, alongside a brief description of their relevant medical history, will be transferred to specialist software hosted at Moorfields Eye Hospital NHS Foundation Trust. These anonymised scans (the trial number will not be displayed) alongside the clinical information will be presented to doctors based at specialist NHS Reading Centres (The Network of Ophthalmic Reading Centres - NetwORC UK) who will make a diagnosis on the scan and clinical information alone.
By comparing the results of the combination of tests reviewed by their eye care team and by independent eye experts the researchers will be able to decide how good each of these tests is at detecting nAMD.

Are there any risks in taking part?
All procedures have some element of risk associated with them, however low. The main risk in this study is that the dye used in FA imaging may make participants feel unwell, and a very small number of people (1 in 100,000) may be allergic to it. However, as the patient has already been referred with suspected nAMD it is likely that they will undergo the procedure anyway, thus taking part in this study is not associated with any additional risk above standard care.

Where is the study run from?
1. Moorfields NHS Foundation Trust (UK)
2. University of Birmingham's Clinical Trials Unit (BCTU) (UK)

When is the study starting and how long is it expected to run for?
May 2021 to October 2023

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)

Who is the main contact?
Dr Konstantinos Balaskas
k.balaskas@nhs.net

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centre

Results and Publications

Study outputs

Editorial Notes

03/06/2024: Publication reference added.
14/09/2022: The recruitment end date was changed from 15/06/2023 to 31/03/2024. Ethics approval and trial website added.
16/06/2021: Internal review.
09/06/2021: Trial's existence confirmed by the NIHR.