Clinical trials for age-related macular degeneration
Researchers are taking note of the Sight Loss and Vision Priority Setting Partnership
The National Institute for Health Research (NIHR) has awarded almost £900,000 to a new clinical trial for age-related macular degeneration (AMD). The study aims to find out whether a magnifying eye implant called OriLens is safe and how good it is at improving vision and quality of life.
More than half a million people in the UK have AMD, which can be diagnosed as ‘wet’ or ‘dry’. Although treatment by eye injection or laser surgery exist for wet AMD, there are no options for people who don’t respond well and there is no treatment for dry AMD available in the clinic.
AMD causes sight loss in the centre of vision. Low vision aids can help but may only give a narrow field of view or may be awkward to use.
Routine NHS health technologies need evidence
A recent new approach has been to use a magnifying lens, like a telescope, that’s implanted into the eye. There are several on the market but there’s not much evidence about how useful they are. This means that the National Institute for Health and Care Excellence (NICE) has not been able to recommend them as a routine option on the NHS.
So Dr Giuliana Silvestri at the Belfast Health and Social Care Trust is leading a team of researchers at 6 institutions around the UK. They will test one make of implant, called the OriLens.
Getting round central vision
AMD affects cells in the macula – a small area in the centre of the light-sensitive layer at the back of the eye (the retina). But the cells that surround the macula still work. So when the centre of the visual field is magnified 2-3 times, it becomes large enough to fall on the working cells around the macula.
OriLens uses mirrors to combine small size plus high magnification. And because it’s smaller it could potentially mean easier and safer surgery and shorter recovery times. Unlike other models, it can also be implanted in eyes that have already had cataracts removed.
The team will recruit around 130 participants with severe sight loss from AMD who have had cataract surgery in both eyes. Half the participants will be given OriLens in one eye, and all will be tested for new glasses and given low vision training. The team will measure how clearly participants can see (visual acuity), reading acuity, reading speed and quality of life after 1 year.
Can we restore sight to people with AMD?
“We’re delighted to see this substantial award from NIHR for high-priority research identified by the Sight Loss and Vision Priority Setting Partnership of patients, carers and health professionals,” said Dr Dolores M Conroy, Fight for Sight’s Director of Research. “This trial addresses the priority that asks what are the best enablement strategies for people with AMD. Implantable telescopes have great potential as an aid to rehabilitation. We look forward to the results of this 3.5-year study.”
More details about the trial are available on the NIHR website.
Meanwhile, Professor Andrew Lotery at the University of Southampton is the UK lead of a multicentre clinical trial of a treatment for late-stage dry AMD (geographic atrophy). The study is still recruiting eligible participants to be treated with the drug lampalizumab, which has been shown in smaller studies to reduce damage from dry AMD by 20%.
For some people with a particular genetic variation, the treatment can reduce damage by 44%. The researchers are trying to reproduce the results in this larger, phase II clinical trial of 2000 patients. The study is due to end in December 2018. If you’re interested in participating in the trial, contact Marie Nelson, senior research sister, on 023 8120 5266 or by email to marie.nelson@uhs.nhs.uk.