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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Neovascular age-related macular degeneration
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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; however, currently there is no cure or effective treatment for this type. 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Inability to comply with the study or follow up procedures2. Pregnant or lactating women3. Women of child bearing potential unless they are using effective methods of contraception (total abstinence, female or male sterilization, barrier contraception, intrauterine device, oral or injectable hormonal methods of contraception)4. Previous treatment for choroidal neovascularisation in the study eye5. Fibrosis consisting of more than 50% of the lesion or involving the centre of the fovea6. Coexisting pathology within 0.5 disc diameters of the fovea that could prevent an improvement in visual acuity in the opinion of the investigator (e.g. macular hole, dense epi Â- retinal membrane)7. Cataract (causing significant visual impairment), aphakia, vitreous haemorrhage, retinal detachment, proliferative retinopathy or CNV due to any cause other than AMD at screening and baseline8. Known allergy to aflibercept or fluorescein9. History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the screening visit10. Any type of systemic disease or treatment that may affect or expect to affect the clinical status of the patient to a significant degree11. Blood pressure of >160mmHg systolic or >100mmHg diastolic at screening or baseline12. Any active periocular infection or inflammation at screening or baseline13. Uncontrolled glaucoma (30mmHg) at screening or baseline14. Neovascularisation of the iris at screening or baseline15. Treatment with any anti angiogenic drugs to either eye within 3 months of baseline16. Nd-YAG laser capsulotomy within the last 2 months or expected within 6 months of baseline in the affected eye17. Use of other investigational drugs within 30 days18. Use of systemic anti –vascular endothelial growth factor agents within 3 months prior to baseline19. Use of systemic corticosteroids for at least 30 consecutive days within the 3 months prior to baseline20. Current or planned medications known to be toxic to the lens, retina or optic nerve e.g. hydroxychloroquine, desferoxamine, tamoxifen or ethambutol
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Mr
Tom
Szczerbicki
+44 (0)1904 721893
Mate.study@york.nhs.uk
The study is sponsored by York Hospital and funded by Bayer Health Centre.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.
