Date: 13 April 2018
Buckinghamshire residents with a common eye condition are being asked to take part in an NHS trial into whether radiotherapy could replace eye injections.
People in Buckinghamshire with wet age-related macular degeneration (AMD) - which causes vision loss - are being asked to participate in an NHS trial into whether a one-off radiation treatment is a safe and effective alternative to eye injections.
Wet AMD occurs when abnormal blood vessels form underneath the macula, which is responsible for central vision, and damage its cells. Sight loss is often rapid, although it can be gradual.
The standard treatment for wet AMD involves regular injections of anti-vascular endothelial growth factor (anti-VEGF) drugs every few weeks, which prevent further blood vessels developing. However, side effects include eye pain, inflammation, bleeding and irritation.
The stereotactic radiotherapy for wet AMD (STAR) study is comparing anti-VEGF injections with stereotactic radiotherapy (SRT).
This uses a robotically controlled machine, IRay, to aim three beams of radiation at the macula. It is hoped the radiation will stop the blood vessels that cause wet AMD from leaking.
Patients sit in a chair for 10 to 20 minutes while the machine beams radiation into their eyes. The procedure is usually painless.
The STAR study is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership.
It is being run by King’s College London and will enrol 411 patients from 25 hospitals throughout the UK. Buckinghamshire Healthcare NHS Trust plan to recruit 30 patients.
Buckinghamshire patients visiting AMD clinics at Amersham Hospital are asked if they want to take part and undergo screening tests at Stoke Mandeville Hospital, Aylesbury, to see if they are eligible.
Two thirds of participants are randomly allocated to receive stereotactic radiotherapy and a third receive a ‘sham’ treatment, in which the machine does not use radiation, to compare the two. They are not told which treatment they are getting.
Patients choose to receive their SRT treatment at one of three sites: King's College Hospital in London, Solihull Hospital in the West Midlands or Royal Hallamshire Hospital in Sheffield. Travel costs are reimbursed.
They will have monthly follow-up visits for two years at Stoke Mandeville Hospital. If patients are still showing symptoms of wet AMD, eye injections will be given.
The first Buckinghamshire patient is Lydia Wilkins, 76, of Bledlow Ridge.
Mrs Wilkins was diagnosed with wet AMD in August 2016 after experiencing double-vision.
The grandmother-of-four said: “My husband was driving us home and I could see white lines down the middle of the road, but there were two of them, which made me think ‘why are there double white lines?’. The next day, we were going out under the railway bridge and I saw a double decker train, which rather worried me.
“I went to my optician who made me an appointment at the Stoke Mandeville Hospital and I had to go for a test there, where they told me it was wet age-related macular degeneration. It was a bit bewildering because I didn’t know what it was. I’m used to the idea now and I accept it, you have to.
“I don’t drive at night anymore. If the light’s bad, I don’t drive. That one’s out. Other than that, I’ve managed quite well. I do my knitting. I don’t read as much as I used to because I found that quite difficult.”
Symptoms of wet AMD include blurred central vision, difficulty reading, colours appearing less vibrant and faces being difficult to recognise.
Age-related macular degeneration is the leading cause of vision loss in the UK, affecting more than 600,000 people, usually over the age of 50.
Mrs Wilkins volunteered for the STAR study after hearing about it from her doctor.
She said of her decision to take part in research: “I thought it might do somebody else some good. It might not do me any good, but I have grandchildren and I hope that they don’t have the same effects and I’m just eager to help other people.
“It’s the sort of thing I do, I’m in Lions International. We invented the white stick for blind people, and we started guide dogs for the blind. As I’m a Lion, I thought I should help other people with their conditions. That’s my thinking.”
Lions Clubs International conducts fundraising activities to help local and global communities.
Speaking of her treatment at King's College Hospital, Mrs Wilkins said: “There’s nothing terrible about it, it’s a good experience. It doesn’t hurt you, it’s quite straightforward really.
“I would personally recommend taking part in research. If it helps someone else, that’s what it’s all about.”
Mr Mandeep Singh Bindra (pictured), consultant ophthalmologist and the study’s principal investigator at Buckinghamshire Healthcare NHS Trust, said: “Current treatment for wet macular degeneration places a huge burden on patients, their relatives as well as on hospital eye departments and their staff.
“This involves injections into the eye which need to be carried out every few weeks, often for many years. This is a challenge both for the NHS and for patients and relatives who need to bring these usually elderly patients to their appointments.
“Stereotactic radiotherapy may reduce the number of injections that patients require and help maintain better vision than injections alone.
“Each injection is an invasive procedure which can be uncomfortable and carries a small risk of complications which may lead to complete loss of sight.
“If STAR shows that the SRT treatment is effective, it may mean that patients require fewer visits to the hospital, fewer injections and maintain better vision in the long term.”
The STAR study is currently open to recruitment. For more information visit starstudy.org.uk or call 01494 734958.
Participating in health research helps develop new treatments, improve the NHS and save lives. The NHS supports research such as comparing new medical devices to current treatments to see which is superior.
Patients are encouraged to ask their doctor about research opportunities and view trials seeking volunteers at The UK Clinical Trials Gateway at www.ukctg.nihr.ac.uk.