Background: Bevacizumab (Avastin�®) is as effective as ranibizumab (Lucentis�®) in the treatment of neovascular\nage-related macular degeneration (nAMD). However it has two important structural differences. First, it has two active\nsites instead of one; second, it retains the Fc portion of the antibody which would be expected to confer a significantly\nlonger half-life. These agents have been associated with systemic complications including strokes, so it is desirable to\nuse the smallest effective dose. Furthermore, the standard dosing regimen requires monthly hospital visits, which\npresent a significant challenge both to the hospital services and to the patients (who are elderly).\nMethods/Design: Patients ?50 years who are eligible for anti-vascular endothelial growth factor (VEGF) treatment of\nnAMD in the NHS, who are either newly referred for treatment or have reactivation of nAMD and who have not received\ntreatment to either eye for the previous six months.\nWe have designed a factorial multi-centre masked randomised controlled trial using bevacizumab as the intervention,\nwith patients randomised to one of four arms: to standard or low dose and to monthly or two-monthly patient review.\nThe aim is to recruit sufficient patients (around 1,000) to obtain 304 patients meeting the endpoint over a four-year\nperiod. The primary endpoint is time to treatment failure to be analysed using Cox regression.\nDiscussion: This randomised control trial will show if half dose and two monthly as required is as effective as full dose\nand monthly regimes. A two monthly as required regimen of Bevacizumab would significantly reduce both the cost\nand the service delivery burden for the treatment of nAMD while a reduced dose would be expected to enhance the\nsafety profile of this treatment regime.
Loading....