02 August 2018
STAR Study
A clinical trial using a robotically-controlled system to
deliver highly-targeted, low-dose radiotherapy to treat patients
with Wet Age-Related Macular Degeneration (AMD) in the hope of
eradicating or reducing eye injections is now available to patients
attending the eye department at Bristol Eye Hospital.
The nationwide study, funded by an NIHR & MRC partnership
and initiated by clinicians at King's College Hospital in London,
is giving new hope to patients with the condition who until now
have faced regular eye injections to preserve their vision.
In the one-off, non-invasive treatment, three rays of
radiotherapy are beamed through the white of the eye to overlap at
the macula. The therapy is delivered by an eye doctor using a
robotically-controlled machine to ensure precision treatment. The
total dose of radiation received by the body is about the same as a
mammogram.
AMD, of which there are two main types (Wet and Dry), affects
patients over 50 and is the leading cause of sight loss in the UK.
The condition develops when the part of the eye responsible for
central vision (the macula) is unable to function as effectively as
it used to. Wet AMD, which usually affects the vision more rapidly,
occurs when abnormal blood vessels grow underneath the macula and
leak fluid. Without treatment, vision can deteriorate rapidly
(within days or weeks).
The standard treatment for Wet AMD involves the injection of
drugs into the eye targeting a chemical called vascular endothelial
growth factor known as VEGF. VEGF causes abnormal blood vessels to
grow and leak fluid under the retina. The injections do not cure
Wet AMD, they just reduce the leakage of fluid from the abnormal
blood vessels. The injections do not make the abnormal blood
vessels go away and unfortunately they often start leaking fluid
again, when the injection wears off after a month or so.
It is anticipated that the new radiotherapy treatment may
actually make the abnormal blood vessels shrink or go away in some
patients and thereby reduce the number of injections required.
Studies have already shown that in carefully selected patients
stereotactic radiotherapy can reduce the number of eye injections
by about half, with many patients needing no further injections at
all, and vision was better than in those who only received eye
injections.
If proved successful, the new treatment will not only be more
convenient for patients, who currently have to visit an eye clinic
on a regular basis, but it will also be more cost-effective for the
NHS. Each dose of the injection costs around £800 and may need to
be repeated multiple times each year, whereas the radiotherapy
treatment costs £1,250 but is required only once.
Mr Richard Haynes, Consultant Ophthalmic Surgeon and Mr Martin
Bennett, Associate Specialist, who are leading the study in Bristol
have said: "We are very excited to be offering this study to
patients under the care of the Bristol Eye Hospital team.
Whilst not all of our patients are suitable for the study, it is a
promising prospect for those that are, with the hope that it may
reduce the number of injections required, thus improving patient
experience. We have already exceeded our target recruitment,
but we are keeping recruitment to the study open for additional
participants to become involved should they meet the criteria and
wish to take part".
"Patients have their initial assessment at Bristol Eye Hospital
before travelling to King's College Hospital for a one-off visit
for treatment with stereotactic radiotherapy. They return to
Bristol for monthly assessments and injections if required, for the
duration of the trial."
The randomised trial treats two-thirds of participants with the
active treatment and one-third with a placebo. The standard
treatment of eye injections is continued on patients throughout the
trial, if they need it.
We recommend that patients visit the STAR website ( www.starstudy.org.uk) and
discuss the study with their local ophthalmologist.
Following this if they may be suitable, contact the Clinical
Research Unit at Bristol Eye Hospital (tel: 0117 342 4770, email:
BEHCRUAppointments @UHBristol.nhs.uk)
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.
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