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FASBAT

  • Research type

    Research Study

  • Full title

    Observing Fibrosis, Macular Atrophy and Sub retinal Highly Reflective Material - Before and After Intervention with Anti-VEGF Treatment: An extension to the EDNA Study

  • IRAS ID

    197731

  • Contact name

    Richard Gale

  • Contact email

    richard.gale@york.nhs.uk

  • Sponsor organisation

    York Teaching Hospital NHS Foundation Trust

  • Duration of Study in the UK

    6 years, 0 months, 1 days

  • Research summary

    Patients with nvAMD in one eye have an increased probability of developing the condition in their second eye. It is therefore important to monitor patients and to detect the development of nvAMD early on so that treatment can be initiated to prevent loss of sight. The current EDNA study aims to recruit 560-600 newly diagnosed nvAMD patients over a 16 month period to determine the sensitivity and specificity of two comparator tests on detecting nvAMD development in the fellow eye. The EDNA study will therefore observe a large cohort of patients, monitor disease progression in these patients and collect important and useful data about Geographic Atrophy. This FASBAT study exploits the opportunity provided by EDNA to observe patients both prior to and after the onset of nvAMD in their second eye. The primary aim of FASBAT is to follow those patients who develop nvAMD in their second eye, to look at the change in fibrosis and Sub retinal Highly Reflective Material (SHRM) in the initial nvAMD eye following commencement of anti-VEGF therapy and to compare this to the rate of change of fibrosis and SHRM in the fellow eye in patients who convert in this eye. Observing patients before and after treatment for wet AMD enables investigation of side effects of treatment. Loss of the light sensitive and associated support cells of the retina, termed atrophy may be an important side effect. Capturing vision data and quality of life data of patients will enable the investigation of the disease burden associated with these tissues.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    16/YH/0089

  • Date of REC Opinion

    2 Mar 2016

  • REC opinion

    Favourable Opinion