Case study: Cathy from the PINNACLE study tells us why taking part is the right thing to do

These are the words of Cathy Hill, a participant on the PINNACLE study at St Mary’s Hospital on the Isle of Wight.

Led by Andrew Lotery the University of Southampton, and with funding from The Wellcome Trust and the University of Southampton’s Gift of Sight appeal, The PINNACLE Study was developed with the aims of better understanding the processes behind the progression of Age-related macular degeneration (AMD),  and identifying the individual risk factors that contribute to this. 

AMD affects 200 million people globally, with this number expected to rise to nearly 300 million by 2040. Severity of AMD is classified as early, intermediate or late, and in its late stage, is a common cause of blindness. At present, it is not clearly understood who will progress to the sight-threatening stage of the disease, or the speed at which this will occur.

For Cathy, it was found that she had what is known as drusens (small yellow deposits of protein and fat that develop under the retina). The presence of many small and larger drusen is often an early sign of AMD. For someone whose passion is mother nature it was at the back of her mind that she might be unlucky for it to develop into losing her normal eyesight.

“I just love mother nature and if I couldn’t see those things which I see on an everyday basis because of where we’re fortunate to live I think it would be quite devastating to be honest.”

So when Cathy was offered to be part of this study she said “Yes – any part that I can play in research to help find a cure for this disease, can only be a good thing.”

The PINNACLE study is split into two sub-studies: the retrospective and prospective study.

The retrospective PINNACLE study works with hundreds of thousands of high-resolution images of the inside of the eye, from patients with and without AMD. Following a period of teaching by a computer scientist, also known as ‘Machine Learning’, computers can analyse these images and identify any common structural changes occurring in the eyes of those with AMD. Once the computers have learnt this, it is anticipated they will also be able to identify changes not previously considered. A similar approach has already been used in other conditions such as Alzheimer's disease and has proven to be successful.

The prospective PINNACLE study involves obtaining high-resolution imaging, visual tests and demographic data from participants who are currently in the intermediate stage of AMD, in either one or both of their eyes. The study opened in October 2019, and by the end of the recruitment period in June 2022, had enrolled 429 eligible participants, exceeding the original target of 400. The study has recruited participants across a total of twelve centres: ten in the UK, one in Vienna, Austria and another in Basel, Switzerland.

As part of this study, each participant attends a total of ten study visits: a baseline visit to check eligibility, and a further nine follow up visits, which take place every four months across a three year period. At each visit, participants attend their local study site’s ophthalmology department for a series of eye scans and tests, plus a review of the medications and any changes in their overall health. The images obtained from these visits are then uploaded to a specialist Reading Centre in Vienna, Austria for review. Should any new or significant changes be identified during this review, participants are invited for further imaging of the area(s) of interest.

At the start of this study, participants were also invited to give an optional one-off blood sample, which will be used to help further understand the role of genetics in the development and progression of AMD.

As Cathy says: “It’s really quite simple. I have to go to St Mary’s Hospital on the Island and I have to go to the eye department, three times a year and they do various scans. When I turn up I go to reception and I just say ‘I’m Cathy Hill. I’m part of the research programme’ and I’m always treated a little bit like royalty. They’re always saying thank you to me the whole time all the way through.”

Commenting, Natalie Clarke, Clinical Trial Project Manager for PINNACLE, says: “It is hoped that the outcome of this study will help improve the way AMD is diagnosed and managed. In the short term, the ability to identify the most ‘at-risk’ patients in the early stages of their diagnosis will facilitate earlier intervention and promote better outcomes. The longer-term benefits of this knowledge will aid the development of future clinical trials, increase targeted treatment options and overall, provide a more personalised approach to the clinical management of AMD.”

Watch Cathy's Story

Watch Cathy’s story here as she shares her journey on the trial and explains why she feels others should take part in research.