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, FENETRE study group, Claire Bailey, Richard P Gale, Faruque Ghanchi, Robin Hamilton, Aled Jones, Janet Peacock, Sajjad Mahmood, Martin McKibbin, Praveen J Patel, Simon Read, Serena Salvatore, Dawn Sim, 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, FENETRE study group, Claire Bailey, Richard P Gale, Faruque Ghanchi, Robin Hamilton, Aled Jones, Janet Peacock, Sajjad Mahmood, Martin McKibbin, Praveen J Patel, Simon Read, Serena Salvatore, Dawn Sim

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.

Keywords: ophthalmology; organisation of health services; protocols & guidelines.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1
Figure 1
Flow chart of study design and participant follow-up. Numbers of patients assessed, excluded and lost to follow are estimated samples based on previous studies. *Due to the COVID-19 pandemic, the 4-weekly follow-up interval was changed to 8-weekly follow-up interval. AMD, age-related macular degeneration.

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