SAFARI
Research type
Research Study
Full title
A phase IV, prospective, open label, uncontrolled, European study in patients with neovascular age-related macular degeneration (nAMD), evaluating the efficacy and safety of switching from intravitreal aflibercept to ranibizumab 05. mg : the SAFARI study.
IRAS ID
151493
Contact name
Karen O'Brien
Contact email
Eudract number
2014-001085-10
Duration of Study in the UK
2 years, 3 months, days
Research summary
AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and blindness registration in the UK . It is a disease which affects the retina (the nerve and blood vessel network at the back of the eye responsible for vision). Patients can suffer with severe visual loss and have difficulties with every day tasks such as recognising faces, reading & driving.
There are two variations of the disease, a 'dry' type & a 'wet' type also known as neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the retina, in part due to higher than normal levels of a protein called Vascular Endothelial Growth Factor (VEGF).
Since the introduction of drugs which block VEGF, visual outcomes for patients with wAMD have dramatically improved.
There are 2 widely used treatments - ranibizumab and aflibercept. Whilst the majority of patients have a successful outcome with treatment, many patients experience suboptimal response. This study will evaluate if these patients experience a benefit from a switch to a different anti-VEGF drug treatment.In this study nAMD patients who are showing no or poor to response to treatment with aflibercept will be switched to ranibizumab to assess if there is any benefit in terms of treatment outcomes.
Patients will visit the hospital clinic 8 times over the 7 - 8 month study period. Monthly ranibizumab injections will be given for the first 3 months, then monthly as required for the next 3 months.
162 patients will be treated in around 33 centres in Europe, of which approximately 127 patients will be included in the UK.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/0262
Date of REC Opinion
22 May 2014
REC opinion
Further Information Favourable Opinion