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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

Lookup NU author(s): Dr Ashleigh KernohanORCiD, Professor Luke ValeORCiD



This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.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.

Publication metadata

Author(s): Learoyd AE, Tufail A, Bunce C, Keane PA, Kernohan A, Robinson E, Jaber A, Sadiq S, Harper R, Lawrenson J, Vale L, Waterman H, Douiri A, Balaskas K, FENETRE study group

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2021

Volume: 11

Issue: 5

Online publication date: 11/05/2021

Acceptance date: 15/02/2021

Date deposited: 11/06/2021

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group


DOI: 10.1136/bmjopen-2021-049411

PubMed id: 33980536


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Funder referenceFunder name
... and the Royal College of Physicians, as well as the support from the NIHR Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.
AEL and AD also acknowledge funding support from the NIHR Applied Research Collaboration South London at King’s College Hospital NHS Foundation Trust ...
National Institute for Health Research (NIHR) Health Technology Assessment grant