VITAL

  • Research type

    Research Study

  • Full title

    Individualizing therapy for neovascular age-related macular degeneration with aflibercept

  • IRAS ID

    155218

  • Contact name

    Praveen Patel

  • Contact email

    Praveen.patel@moorfields.nhs.uk

  • Sponsor organisation

    Moorfields Eye Hospital

  • Eudract number

    2014-002381-73

  • Research summary

    The purpose of this study is to estimate the average change in vision in patients with wet age-related macular degeneration (wAMD) treated with aflibercept (Eylea®). Aflibercept (Eylea®) is a licensed medication and we plan to use it for its licensed indication. The aim is to achieve an acceptable trade-off between treatment benefit and the number of hospital visits. The study will last for approximately 24 months, and during this time recruited patients will be asked to come up to the clinic for up to 14 visits. The duration of the visits varies and will depend on several factors including the number of procedures required by the study protocol.

    During the study recruited patients will receive monthly aflibercept injections for the first three months and then every two months for a further five injections. After this, the interval between injections will be increased where safe to do so up to a maximum interval of three months between injections.

    We plan to enrol 50 patients at Moorfields Eye Hospital. This study is being organised by Moorfields Eye Hospital NHS Foundation Trust.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    14/LO/1561

  • Date of REC Opinion

    2 Oct 2014

  • REC opinion

    Further Information Favourable Opinion