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One and Two Year Visual Outcomes from the Moorfields AMD Database - an Open Science Resource for the Study of Neovascular Age-related Macular Degeneration

View ORCID ProfileKatrin Fasler, Gabriella Moraes, Siegfried K. Wagner, Karsten U. Kortuem, Reena Chopra, Livia Faes, Gabriella Preston, Nikolas Pontikos, Dun Jack Fu, Praveen J. Patel, Adnan Tufail, Aaron Y. Lee, Konstantinos Balaskas, Pearse A. Keane
doi: https://doi.org/10.1101/450411
Katrin Fasler
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
2Department of Ophthalmology, University Hospital Zurich, Zurich, Switzerland
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  • ORCID record for Katrin Fasler
Gabriella Moraes
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Siegfried K. Wagner
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Karsten U. Kortuem
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
3Munich, Germany
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Reena Chopra
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Livia Faes
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
4Eye Clinic, Cantonal Hospital of Lucerne, Lucerne, Switzerland
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Gabriella Preston
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Nikolas Pontikos
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Dun Jack Fu
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Praveen J. Patel
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Adnan Tufail
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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Aaron Y. Lee
5Department of Ophthalmology, University of Washington, Seattle, USA
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Konstantinos Balaskas
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
6School of Biological Sciences, University of Manchester, Manchester, UK
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Pearse A. Keane
1NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
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ABSTRACT

Objectives To analyse treatment outcomes and share clinical data from a large, single-center, well-curated database (8174 eyes / 6664 patients with 120,756 single entries) of patients with neovascular age related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (VEGF). By making our depersonalised raw data openly available, we aim to stimulate further research in AMD, as well as setting a precedent for future work in this area.

Setting Retrospective, comparative, non-randomised electronic medical record (EMR) database cohort study of the UK Moorfields AMD database with data extracted between 2008 and 2018.

Participants 3357 eyes/patients (61% female). Extraction criteria were ≥ 1 ranibizumab or aflibercept injection, entry of “AMD” in the diagnosis field of the EMR, and a minimum of one year of follow-up. Exclusion criteria were unknown date of first injection and treatment outside of routine clinical care at Moorfields before the first recorded injection in the database.

Main outcome measures Primary outcome measure was change in VA at one and two years from baseline as measured in Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Secondary outcomes were the number of injections and predictive factors for VA gain.

Results Mean VA gain at one-year and two years were +5.5±0.5 and +4.9±0.68 letters respectively. Fifty-four percent of eyes gained ≥5 letters at two years, 63% had stable VA (±≤14 letters), forty-four percent of eyes maintained good VA (≥70 letters). Patients received a mean of 7.7±0.06 injections during year one and 13.0±0.2 injections over two years.

Younger age, lower baseline VA, and more injections were associated with higher VA gain at two years.

Conclusion This study benchmarks high quality EMR study results of real life AMD treatment and promotes open science in clinical AMD research by making the underlying data publicly available.

Strengths and limitations of this study

  • - Large sample size, retrospective, single centre, electronic medical record database study

  • - High quality real life data

  • - Open science approach with sharing of depersonalised raw data

Abbreviations
AMD
age related macular degeneration
VEGF
vascular endothelial growth factor
VA
visual acuity
ETDRS
Early Treatment Diabetic Retinopathy Study
RCT
randomized controlled trial
LTFU
lost to follow-up
EMR
electronic medical record
NHS
National Health Service
ICHOM
International Consortium for Health Outcomes Measurement FRB - Fight Retinal Blindness
CATT
Comparison of Age-related macular degeneration Treatment Trials
VIEW
Vascular endothelial growth factor Trap-Eye: Investigation of Efficacy and Safety in Wet AMD study

Footnotes

  • Disclosure / Funding Dr. Fasler has received fellowship support from Alfred Vogt Stipendium and Schweizerischer Fonds zur Verhul□tung und Bekal□mpfung der Blindheit. She has been an external consultant for DeepMind.

    Dr. Wagner is an academic clinical fellow funded by the National Institute of Health Research. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, Health Education England or the Department of Health.

    Dr. Keane has received speaker fees from Heidelberg Engineering, Topcon, Carl Zeiss Meditec, Haag-Streit, Allergan, Novartis, and Bayer. He has served on advisory boards for Novartis and Bayer and has been an external consultant for DeepMind and Optos. Dr. Keane is supported by a United Kingdom (UK) National Institute for Health Research (NIHR) Clinician Scientist Award (NIHR-CS--2014-12-023). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health.

    Dr. Patel has received speaker fees from Novartis, UK, Bayer UK, and Roche UK and has received an advisory board honorarium from Novartis UK, Bayer UK.

    Dr. Lee has received research funding from Novartis, NVIDIA, and Microsoft Corporation. He is supported by the National Institute of Health (K23EY029246) and Research to Prevent Blindness.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license.
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Posted November 04, 2018.
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One and Two Year Visual Outcomes from the Moorfields AMD Database - an Open Science Resource for the Study of Neovascular Age-related Macular Degeneration
Katrin Fasler, Gabriella Moraes, Siegfried K. Wagner, Karsten U. Kortuem, Reena Chopra, Livia Faes, Gabriella Preston, Nikolas Pontikos, Dun Jack Fu, Praveen J. Patel, Adnan Tufail, Aaron Y. Lee, Konstantinos Balaskas, Pearse A. Keane
bioRxiv 450411; doi: https://doi.org/10.1101/450411
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One and Two Year Visual Outcomes from the Moorfields AMD Database - an Open Science Resource for the Study of Neovascular Age-related Macular Degeneration
Katrin Fasler, Gabriella Moraes, Siegfried K. Wagner, Karsten U. Kortuem, Reena Chopra, Livia Faes, Gabriella Preston, Nikolas Pontikos, Dun Jack Fu, Praveen J. Patel, Adnan Tufail, Aaron Y. Lee, Konstantinos Balaskas, Pearse A. Keane
bioRxiv 450411; doi: https://doi.org/10.1101/450411

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