Date: 2012-07-11
Type of information:
phase:
Announcement:
Company: The University of Nottingham (UK)
Product: Avastin® (bevacuzimab)
Action
mechanism: In wet AMD, abnormally high levels of vascular endothelial growth factor (VEGF) are secreted in the eye, promoting the growth of new abnormal blood vessels. The Lucentis® and Avastin® both work by blocking the effect of the VEGF.
Disease: wet age-related macular degeneration (AMD)
Therapeutic area: Ophtalmological diseases
Country: UK
Trial
details: The Nottingham researchers are currently seeking to recruit around 2,000 patients aged 50 plus, at a number of centres around the East Midlands, who have recently been referred for wet AMD and who have not received treatment to either eye for the condition during the previous six months. The TANDEM trial, being conducted through the Clinical Trials Unit based at The University of Nottingham, is due to run until June 2016.
Latest
news: The University of Nottinghamto has announced that Nottingham researchers are leading a study to test the effectiveness of bevacuzimab (Avastin®) in the treatment of wet age-related macular degeneration (AMD). It could prove the case for replacing the drug Ranibuzumab (Lucentis®), which is currently recommended by the National Institute for Health and Clinical Excellence (NICE) for the treatment of wet AMD.
The four-year TANDEM study is being led by Mr Alexander Foss, an honorary special lecturer in the School of Biomedical Sciences at The University of Nottingham and Consultant Ophthalmologist at Nottingham University Hospitals NHS Trust. Nottingham researchers are seeking to test whether a lower dose of bevacizumab can be used in place of a higher dose and whether two-monthly rather than monthly review can maintain the same treatment results.
Nottingham University has indicated that the move hit the headlines recently following the decision by pharmaceutical company Novartis — maker of the drug Lucentis — to challenge the decision by seeking a judicial review of the policy to pay for Avastin® on the NHS. However, at a time when the NHS has been told to find £20 billion in savings by 2015, more cost-effective alternatives for commonly used drugs are hugely attractive to cash-strapped local trusts.
Lucentis® costs in the region of £740 per injection, while Avastin® is a fraction of the cost at £60 per injection. The Nottingham research is aiming to establish whether it could reduce the financial burden on the NHS further by being offered in a smaller dose and at less regular intervals.
Two major trials — CATT and IVAN (which also involved researchers from The University of Nottingham) — have reported showing that Avastin and Lucentis are of similar effectiveness. The TANDEM trial is designed to complement these existing trials and in particular to address the important issues of dose (given the safety concern raised with these agents) and frequency of dosing. The trial is designed as a two by two factorial study generating four equal sized groups. One factor is the dose, with half the patients receiving standard dose and the other half receiving a low dose equivalent to half the standard dose and the other factor being frequency, with half the patients being seen monthly and half bimonthly.
