Neovascular Age-related Macular Degeneration Clinical Trial
Official 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 0.5mg.
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 evaluated if these patients experience a benefit from a switch to a
different antiVEGF drug treatment.
In this study nAMD patients who are showing no or poor to response to treatment with
aflibercept were switched to ranibizumab to assess if there is any benefit in terms of
treatment outcomes.
Patients visited the hospital clinic 8 times over the 7 - 8 month study period. Monthly
ranibizumab injections were given for the first 3 months, then monthly as required for the
next 3 months.
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