Clinical scientists and their teams are helping to push patient recruitment ahead within a clinical trial that could help prevent blindness from bleeding as a complication of wet age-related macular degeneration (AMD). Fight for Sight recognises and wants to highlight the important role both the clinical teams and the patients who participate in research play in the success of a trial. Here we focus on the clinical team and their achievements.
Participants are taking part in the TIGER clinical trial, which we’re funding with support from EURETINA. Clinical trials are one of the last stepping stones to direct patient benefit and TIGER aims to be the largest trial to date comparing treatments for haemorrhages related to wet AMD.
Its successful outcome will provide evidence to influence clinical guidance on the most appropriate treatment to save sight.
Key to the success of any clinical trial, is not only having a great clinical team, but also recruiting the right people to take part – it’s one of the most difficult elements. One site is excelling at getting people to sign up. Despite being a less populated area of the UK, Maidstone and Tunbridge Wells Trust have recruited 12 of the 117 patients enrolled so far. Its recruitment total increased by over 30 per cent this year. So how have they managed to overcome recruitment barriers? Why is this so critical?
"This is the first trial to provide good quality evidence on how best to treat this disease.”
Advancing our understanding of wet age-related macular degeneration
Some 600,000 people in the UK have age-related macular degeneration. Maidstone and Tunbridge Wells Trust treats over a thousand patients a month.
The TIGER trial is important to advance our understanding of wet age-related macular degeneration and specifically haemorrhaging (severe bleeding) in the eye. Haemorrhaging in the macula (or ‘submacular haemorrhaging’) is an uncommon occurrence in wet AMD but hospitals still see several patients a year with this devastating complication, one that can cause permanent loss of vision without the right treatment.
Mr Luke Membrey, consultant ophthalmologist leading the Maidstone and Tunbridge Wells Trust site, said: “Submacular haemorrhaging in the context of wet AMD so often has a catastrophic impact on patients and their families. This is the first trial to provide good quality evidence on how best to treat this disease.”
For many patients, the affected eye is the one that previously had better vision, and they suddenly find that they can no longer read, drive, or recognise their loved ones.
Challenges of recruiting for the TIGER clinical trial
Following a submacular haemorrhage patients need treatment quickly, which makes recruitment for the clinical trial challenging. Clinicians need to get patients into hospital, discuss trial procedures with the patient and get formal consent, conduct the trial assessment, as well as organising and perform the surgery – all within two weeks.
This short time frame makes trial recruitment difficult, with patients sometimes presenting too late, because they don’t realise they need to seek help urgently.
Recruitment success: Maidstone and Tunbridge Wells Trust
The team at Maidstone and Tunbridge Wells Trust credit their success to a team-based approach. This includes engaging with community optometrists to let them know the importance of rapid referral, as well as explaining how to ensure patients are seen quickly through their fast-track wet AMD pathway. This pathway is reviewed every day by a retinal specialist, and their research team is flexible and able to arrange assessments rapidly.
The team also note that the Maidstone and Tunbridge Wells Trust management recognises both the importance of research and the need for speedy treatment for these patients.
Having this recognition alongside the support of several expert retinal surgeons means they are often able perform the surgery within a few days. This multi-disciplinary team effort is crucial in clinical trial recruitment, particularly when there is a short window for treatment.
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