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

• Published in: BMJ open Vol. 11; no. 5; p. e049411
• Main Authors: Learoyd, Annastazia E, Tufail, Adnan, Bunce, Catey, Keane, Pearse A, Kernohan, Ashleigh, Robinson, Emily, Jaber, Alijazy, Sadiq, Saqlain, Harper, Robert, Lawrenson, John, Vale, Luke, Waterman, Heather, Douiri, Abdel, Balaskas, Konstantinos
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 11.05.2021; BMJ Publishing Group
• Series: Protocol
• Subjects: Age; Angiogenesis Inhibitors - therapeutic use; Classification; Clinical medicine; Cost analysis; COVID-19; Diabetes; Diabetic retinopathy; Follow-Up Studies; Growth factors; Hospitals; Humans; Intervention; London; Macular degeneration; Ophthalmology; Optometry; Patients; Primary care; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; State Medicine; Vascular Endothelial Growth Factor A; Visual Acuity; Wet Macular Degeneration; London; United Kingdom > UK; protocols & guidelines; organisation of health services; ophthalmology
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-049411

ObjectiveManagement 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/designThis 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 disseminationResearch 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 numberNCT03893474.