TERRA - Treat and Extend Ranibizumab Regimen for AMD
Clinical outcomes and Resource benefits from Treat and Extend Ranibizumab Regimen for neovascular age related macula degeneration on real world settings of the National Health Services of the United Kingdom (The TERRA study)
Yit Chiun Yang
Novartis Pharmaceuticals UK Ltd
Duration of Study in the UK
1 years, 4 months, 4 days
In September 2014 the summary of product characteristics (SpC) of Ranibizumab (Lucentis) was updated to allow the treatment of patients in accordance with a treat- and-extend (T&E) regimen: “If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD. If disease activity recurs, the treatment interval should be shortened accordingly.” This was updated in order to minimize the number of intravitreal treatment (IVT) and monitoring visits for patients treated with Ranibizumab.
The rationale for this study is to provide, a minimum of 2 year evaluation of the efficacy of patients receiving ranibizumab injections, for neovascular age-related macular degeneration (nAMD,) following the T&E approach and the cost of the treatment in UK clinical setting.
This includes visual acuity (sharpness of vision) and central retinal thickness (CSRT)(retinal morphology change) changes over time and how frequently patients are treated in the clinic over a 2 year period (1 year of prospective and a minimum of 1 year of retrospective). Further to that, resource used and the cost of the T&E regime information will be collected in order to identify the cost of the treatment type. Additionally these clinical and non-clinical outcomes will be compared to the PRN regimen where patients attend monthly visits regardless of whether or not they will be receiving an injection of Ranibizumab (Lucentis®).
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
Date of REC Opinion
9 Aug 2016