Extrait

Background and study aims Age-related macular degeneration (AMD) is the most common cause of vision loss in people over 50. It involves the gradual damage to a part of the eye called the macula. The macula is a tiny area at the centre of the retina (the layer at the back of the eye which is sensitive to light), which is responsible for central vision (seeing what is directly ahead). Over time, the damage to the macula can lead to central vision becoming distorted or blurry, eventually causing a blank patch in the centre of your vision. In most cases, AMD is caused by fatty-protein deposits called drusen collecting under the retina (dry AMD) over a long period of time; currently there is no cure or effective treatment for this type however. About 10% of people suffering from AMD have what is known as wet AMD (or neovascular AMD). In wet AMD, the macula becomes damaged and new blood vessels start to grow behind the retina. These blood vessels are generally very weak and prone to leakage, causing the macula to swell and vision to deteriorate very quickly. Aflibercept is a drug treatment known as an anti-VEGF (anti-vascular endothelial growth factor). By injecting it directly into the eye, it works by preventing the weak, leaky blood vessels from growing (by blocking the action of the protein responsible). Currently, the recommended dose is 2mg once every eight weeks after the loading dose (initial large dose of a medicine used to ensure quick benefits), however more research is needed to find out if this is the most appropriate dose for everyone. The aim of this study is to compare the effects of standard treatment to a treat and extend regime, which uses the initial phases of a regimen to find the best dosing regimen for an individual patient. Who can participate? Adults over 50 suffering from bad eyesight due to wet AMD. What does the study involve? Participants are randomly allocated to one of two groups. Participants in both groups receive an initial three 2mg doses of aflibercept, given by intravitreal injection (an injection into the eye), spaced four weeks apart. Following this, for participants in the first group, the interval between treatments is extended to once every 8 weeks for the first year of treatment. In the second year of treatment, the treating physician can extend the intervals between treatments at their discretion. For participants in the second group, the treating physician is able to extend the treatment intervals at their discretion until the most appropriate dosing regimen for each individual participant is found. At the end of the study, the potential benefits of each dosing method are compared, in order to find the best way to conduct a larger study in the future. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? York Hospital (UK) When is the study starting and how long is it expected to run for? December 2015 to June 2015 Who is funding the study? Bayer Health Centre (UK) Who is the main contact? Ms Tracey Dorey

Critère d'inclusion

• Topic: Ophthalmology; Subtopic: Eye (all Subtopics); Disease: Ophthalmology

Liens

• ictrp
• isrctn