Age related Macular Degeneration in People with Diabetes Mellitus-V2.1

  • Research type

    Research Study

  • Full title

    Study of the association between age-related macular degeneration (AMD), diabetes mellitus and diabetic retinopathy in people attending diabetic retinopathy screening programme in Liverpool

  • IRAS ID

    262075

  • Contact name

    Dewi Fathin Romdhoniyyah

  • Contact email

    d.f.romdhoniyyah@liverpool.ac.uk

  • Sponsor organisation

    University of Liverpool

  • Clinicaltrials.gov Identifier

    RD&I 5880, RD&I Number Royal Liverpool University Hospital

  • Duration of Study in the UK

    3 years, 0 months, 30 days

  • Research summary

    Aim
    To investigate the relationship between age-related macular degeneration (AMD), diabetes, diabetic medication, and diabetic retinopathy (DR).

    Research Questions
    1. What is the prevalence, incidence, and progression of AMD in people with diabetes, in association with DR status?
    2. What is the risk-factors of AMD development and progression in people with diabetes, in association with DR status?
    3. Does the history of anti-diabetic medication alter the risk of AMD and DR development and progression in people with diabetes?
    4. What are the clinical characteristics of neovascular AMD in people with diabetes mellitus in association with DR status?

    Hypothesis
    • The development and progression of AMD will be affected by DM, diabetes medication, and DR.

    Methods and Outputs
    The study is an extension of already approved study "Individualized Screening for Diabetic Retinopathy (ISDR)" (ISDR Protocol WS B, C and D Version 1.1 8th Apr 2013). The ISDR study is a study jointly-sponsored by the University of Liverpool (reference number: UoL000951) and the Royal Liverpool and Broadgreen University Hospital Trust, RLBUHT (RD&I numbers: 4262) and approved by a Research Ethics Committee (reference number: 13/NW/0196) on 28th March 2013.
    We would use the data to help us decide when individual people should come for screening based on their risk factors, especially the risk factors of AMD in people with diabetes mellitus in the association of its diabetic retinopathy status and diabetic medication. Opt-out consent approach has been reviewed and agreed from North West – Preston REC to do research. A PhD student will perform grading for retinal image data. Only data from people who already agreed to be involved and donated the data in the ISDR research will use in the analysis. The study is expected to result in new generalisable knowledge suitable for publication and PhD thesis.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    19/LO/1201

  • Date of REC Opinion

    8 Aug 2019

  • REC opinion

    Favourable Opinion