Macustar UK

  • Research type

    Research Study

  • Full title

    Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR

  • IRAS ID

    237357

  • Contact name

    Maeve McGovern

  • Contact email

    mmcgovern@ucc.ie

  • Sponsor organisation

    University of Bonn, Germany

  • Clinicaltrials.gov Identifier

    NCT03349801

  • Duration of Study in the UK

    3 years, 11 months, 28 days

  • Research summary

    Age related macular degeneration (AMD) is the commonest cause of visual loss in Europe, it causes progressive loss of central vision. There are 2 forms of the disease 'Wet' and 'Dry'. At present we only have treatment for the late ‘wet’ form, we do not have treatments for the early wet form (which is much more common) or for the late ‘dry’ manifestations. Thus, it is important to develop interventions for early forms of AMD. In order to do this we need to find the most appropriate tools to implement and analyze the efficacy of interventions in clinical trials of AMD. We hope that the MACUSTAR study will provide these much needed tools.

    MACUSTAR combines Europe’s most relevant clinical and scientific expertise in a group which includes 20 designated clinical sites across seven countries in Europe.
    750 subjects will be recruited at 20 clinical sites from seven EU countries (Denmark, France, Germany, Italy, Portugal, Netherlands and United Kingdom). There will be 3 sites in the UK. Each site will recruit 30-40 subjects .

  • REC name

    London - Queen Square Research Ethics Committee

  • REC reference

    18/LO/0145

  • Date of REC Opinion

    20 Mar 2018

  • REC opinion

    Further Information Favourable Opinion