The MATE study : a 24 month, multicentre, pilot, randomised controlled trial comparing standard care with individualised treat and extend regimen for treatment of neovascular age-related macular degeneration with aflibercept
Thesis or dissertation
- © 2019 Archana Airody. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright holder.
Purpose: Various treatment regimens have been described for anti-vascular endothelial growth factors (VEGF) in neovascular age-related macular degeneration (nvAMD). Recently, these include treating nvAMD with aflibercept using a ‘Treat & Extend’ (T&E) regimen. However, important questions regarding efficacy and treatment burden remain unanswered. The MATE study was a 24-month, prospective, multicentre, pilot, randomised controlled trial (RCT) comparing standard care with T&E in treating patients with aflibercept, in order to inform a future large-scale RCT.
Methods: The study adopted a mixed methodology, with the primary outcome to assess feasibility by recruitment rates and in-depth interviews of trial staff at the end of recruitment and year one. All interviews were transcribed and analysed using thematic analysis. Forty patients were randomised to receive aflibercept for nvAMD as per either standard care or a T&E regimen across the UK in six NHS Ophthalmology units. Baseline demographics, mean change in visual acuity and central retinal thickness from baseline to 12 and 24 months, and number of treatments and visits over 24 months were collected as secondary outcomes.
Results: The recruitment rate was 3.07 participant/month. Key themes in recruitment phase interviews were human factors, protocol-related issues, recruitment processes and challenges; key themes in year one interviews were variation in practice and challenges. Both arms showed a trend towards gain in visual acuity in the first year which was not maintained in the standard care arm at the end of 24 months. These were achieved with one less treatment in the T&E arm.
Conclusion: Minimising set up delays, optimising recruitment strategy, accounting for variation in practice at sites are key factors in the recruitment and running of a multicentre, randomised controlled trial in this context.
- Hull York Medical School, The University of Hull and the University of York
- Gale, Richard; Baseler, Heidi
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