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

BMJ Open. 2021 May 11;11(5):e049411. doi: 10.1136/bmjopen-2021-049411.

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.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angiogenesis Inhibitors* / therapeutic use
  • Follow-Up Studies
  • Humans
  • London
  • Prospective Studies
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • State Medicine
  • Vascular Endothelial Growth Factor A
  • Visual Acuity
  • Wet Macular Degeneration*

Substances

  • Angiogenesis Inhibitors
  • Vascular Endothelial Growth Factor A

Associated data

  • ClinicalTrials.gov/NCT03893474