FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial

Annastazia E Learoyd, Adnan Tufail, Catey Bunce, Pearse A Keane, Ashleigh Kernohan, Emily Robinson, Alijazy Jaber, Saqlain Sadiq, Robert Harper, John Lawrenson, Luke Vale, Heather Waterman, Abdel Douiri, Konstantinos Balaskas

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

Objective Management of age-related macular degeneration (AMD) places a high demand on already constrained hospital-based eye services. This study aims to assess the safety and quality of follow-up within the community led by suitably trained non-medical practitioners for the management of quiescent neovascular AMD (QnAMD). Methods/design This is a prospective, multisite, randomised clinical trial. 742 participants with QnAMD will be recruited and randomised to either continue hospital-based secondary care or to receive follow-up within a community setting. Participants in both groups will be monitored for disease reactivation over the course of 12 months and referred for treatment as necessary. Outcomes measures will assess the non-inferiority of primary care follow-up accounting for accuracy of the identification of disease reactivation, patient loss to follow-up and accrued costs and the budget impact to the National Health Service. Ethics and dissemination Research ethics approval was obtained from the London Bloomsbury Ethics Committee. The results of this study will be disseminated through academic peer-reviewed publications, conferences and collaborations with eye charities to insure the findings reach the appropriate patient populations. Trial registration number NCT03893474.

Original languageEnglish
Article numbere049411
Pages (from-to)e049411
JournalBMJ Open
Volume11
Issue number5
DOIs
Publication statusPublished - 11 May 2021

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