Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT)
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Wet age-related macular degeneration is the most common cause of blind registration in the
United Kingdom (UK). Standard treatment involves regular eye injections of a drug called
ranibizumab (Lucentis). For most patients, ranibizumab maintains their vision but the effect
of the drug is temporary, and they therefore require monthly hospital visits and typically
six injections into the eye every year, probably for life.
This study tests a new surgical device that delivers a focal dose of radiation (epimacular
brachytherapy) to the macula (the part inside the back of the eye that gives fine central
vision), to try and reduce or eliminate the need for ongoing, regular eye injections. The
trial compares epimacular brachytherapy to ongoing standard treatment with ranibizumab.
Whereas most studies of this new surgical device target patients who have not yet commenced
any treatment, this study targets those who are requiring frequent eye injections, as there
are limited surgical resources and these resources are best directed to those who have not
fully responded to ranibizumab therapy, or whose response is shortlived. These patients have
the most to gain from a device that may reduce their burden of treatment. The findings in
untreated disease cannot be extrapolated to this discrete subset of patients, hence the need
for a study that targets refractory disease.
It is hypothesised that epimacular brachytherapy will reduce the frequency of Lucentis®
(ranibizumab) re-treatment that patients require, whilst maintaining visual acuity.