Macular EpiRetinal brachytherapy vs Lucentis Only Treatment (MERLOT)

• Research type

  Research Study

• Full title

  Macular EpiRetinal brachytherapy versus Lucentis Only Treatment (MERLOT): A randomized controlled trial of epimacular brachytherapy using the VIDION System versus ranibizumab (Lucentis) monotherapy for the treatment of subfoveal choroidal neovascularization associated with wet age-related macular degeneration in patients who have commenced anti-VEGF therapy

• IRAS ID

  14664

• Contact name

  Timothy L Jackson

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  2009-012509-20

• ISRCTN Number

  Unknown

• Research summary

  Wet age-related macular degeneration is the most common cause of blind registration in the 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.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/21

• Date of REC Opinion

  27 Jul 2009

• REC opinion

  Further Information Favourable Opinion