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

ABSTRACTObjectivesTo 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.SettingRetrospective, comparative, non-randomised electronic medical record (EMR) database cohort study of the UK Moorfields AMD database with data extracted between 2008 and 2018.Participants3357 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 measuresPrimary 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.ResultsMean 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.ConclusionThis 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

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One- and two-year visual outcomes from the Moorfields age-related macular degeneration database: a retrospective cohort study and an open science resource

BMJ Open ◽

10.1136/bmjopen-2018-027441 ◽

2019 ◽

Vol 9 (6) ◽

pp. e027441 ◽

Cited By ~ 9

Author(s):

Katrin Fasler ◽

Gabriella Moraes ◽

Siegfried Wagner ◽

Karsten U Kortuem ◽

Reena Chopra ◽

...

Keyword(s):

Cohort Study ◽

Macular Degeneration ◽

Clinical Care ◽

Real Life ◽

Open Science ◽

Primary Outcome Measure ◽

Age Related Macular Degeneration ◽

Age Related ◽

Study Results ◽

The Uk

ObjectivesTo analyse treatment outcomes and share clinical data from a large, single-centre, 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 set a precedent for future work in this area.SettingRetrospective, comparative, non-randomised electronic medical record (EMR) database cohort study of the UK Moorfields AMD database with data extracted between 2008 and 2018.ParticipantsIncluding one eye per patient, 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 1 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 measuresPrimary outcome measure was change in VA at 1 and 2 years from baseline as measured in Early Treatment Diabetic Retinopathy Study letters. Secondary outcomes were the number of injections and predictive factors for VA gain.ResultsMean VA gain at 1 year and 2 years were +5.5 (95% CI 5.0 to 6.0) and +4.9 (95% CI 4.2 to 5.6) letters, respectively. Fifty-four per cent of eyes gained ≥5 letters at 2 years, 63% had stable VA (±≤14 letters), 44% of eyes maintained good VA (≥70 letters). Patients received a mean of 7.7 (95% CI 7.6 to 7.8) injections during year 1 and 13.0 (95% CI 12.8 to 13.2) injections over 2 years. Younger age, lower baseline VA and more injections were associated with higher VA gain at 2 years.ConclusionThis 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.

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UK Age-Related Macular Degeneration Electronic Medical Record System (AMD EMR) Users Group Report IV

Ophthalmology ◽

10.1016/j.ophtha.2016.07.037 ◽

2016 ◽

Vol 123 (11) ◽

pp. 2386-2392 ◽

Cited By ~ 16

Author(s):

Robert L. Johnston ◽

Aaron Y. Lee ◽

Miranda Buckle ◽

Richard Antcliff ◽

Clare Bailey ◽

...

Keyword(s):

Macular Degeneration ◽

Medical Record ◽

Electronic Medical Record ◽

Electronic Medical Record System ◽

Age Related Macular Degeneration ◽

Record System ◽

Age Related ◽

Group Report ◽

Medical Record System

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Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

European Journal of Ophthalmology ◽

10.1177/11206721211005703 ◽

2021 ◽

pp. 112067212110057

Author(s):

Pierre Gascon ◽

Prithvi Ramtohul ◽

Charles Delaporte ◽

Sébastien Kerever ◽

Danièle Denis ◽

...

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Cumulative Number ◽

Treat And Extend ◽

Treatment Interval ◽

Age Related ◽

Treatment Naïve ◽

The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

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Reply to: ‘Comment on: ‘One-year real-world outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration’

Eye ◽

10.1038/eye.2017.212 ◽

2017 ◽

Vol 32 (2) ◽

pp. 479-481

Author(s):

H Almuhtaseb ◽

A Lotery

Keyword(s):

Macular Degeneration ◽

Real World ◽

Age Related Macular Degeneration ◽

Age Related ◽

One Year

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Real-life results in treating neovascular age-related macular degeneration with anti-VEGF therapy. Analysis of 122 patients from a single centre

Archivos de la Sociedad Española de Oftalmología (English Edition) ◽

10.1016/j.oftale.2021.02.007 ◽

2021 ◽

Author(s):

L. Giralt-Peret ◽

A. Rodríguez-Urzay ◽

S. Pérez-Fernández ◽

N. Martínez-Alday ◽

A. Fonollosa-Calduch

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Single Centre ◽

Anti Vegf ◽

Age Related

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Central retinal thickness fluctuations in patients treated with anti-VEGF for neovascular age related macular degeneration

European Journal of Ophthalmology ◽

10.1177/11206721211037820 ◽

2021 ◽

pp. 112067212110378

Author(s):

Francesco Ciucci ◽

Giuseppina Ioele ◽

Antonio Bardocci ◽

Giorgio Lofoco ◽

Barbara Antonelli ◽

...

Keyword(s):

Macular Degeneration ◽

Retinal Thickness ◽

Treatment Algorithm ◽

Real Life ◽

Principal Component ◽

Age Related Macular Degeneration ◽

Central Retinal Thickness ◽

First Year ◽

Anti Vegf ◽

Age Related

Purpose: This is a retrospective, single-center, non randomized interventional real life study, investigating the correlation between variability of central retinal thickness (CRT) and functional outcomes during 2 years of anti-VEGF therapy in patients treated for neovascular age related macular degeneration (nAMD). Background: CRT fluctuations can depend on various factors such as the correct timing of injections, the therapeutic algorithm, and the number of injections (NI) performed; it is important to understand if CRT fluctuations are responsible for worse visual outcomes and consequently to identify the correct ways to avoid or reduce them. Methods: Forty-one patients were treated for nAMD with aflibercept: 0.5 mg intravitreal aflibercept was administered every 4 weeks during the first 3 months, then bimonthly over the first year, and after the first year adopting a PRN regimen. Standard deviation of CRT (CRT/SD), BCVA, and NI were recorded. Correlation studies were performed by Pearson’s test, Ancova, and Principal Component Analysis. Results: A negative correlation was found between CRT/SD and final BCVA. In patients who lost more than 15 letters, CRT/SD mean was significantly higher in comparison with patients who lost less than 15 letters. Patients with final BCVA >65 letters showed lower CRT/SD values compared to patients with final BCVA ⩽65 letters. Multivariate analysis confirmed that in patients with higher baseline BCVA, improvement of BCVA was correlated to NI, and lower values of CRT fluctuations were observed. Conclusions: CRT fluctuations, even after an appropriate NI given per year, significantly influence BCVA; a proactive treatment algorithm appears crucial when treating patients with nAMD.

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Optimizing the Anti-VEGF Treatment Strategy for Neovascular Age-Related Macular Degeneration: From Clinical Trials to Real-Life Requirements

Translational Vision Science & Technology ◽

10.1167/tvst.4.3.6 ◽

2015 ◽

Vol 4 (3) ◽

pp. 6 ◽

Cited By ~ 20

Author(s):

Irmela Mantel

Keyword(s):

Clinical Trials ◽

Macular Degeneration ◽

Treatment Strategy ◽

Real Life ◽

Age Related Macular Degeneration ◽

Anti Vegf ◽

Age Related

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A Retrospective Analysis of the Real-Life Utilization of Ranibizumab in Patients with Wet Age-Related Macular Degeneration from Portugal

Acta Médica Portuguesa ◽

10.20344/amp.8217 ◽

2017 ◽

Vol 30 (6) ◽

pp. 449 ◽

Cited By ~ 1

Author(s):

Rufino Silva ◽

Carla Goncalves ◽

Angela Meireles ◽

Carla Teixeira ◽

Paulo Rosa ◽

...

Keyword(s):

Optical Coherence Tomography ◽

Visual Acuity ◽

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Optical Coherence ◽

Age Related ◽

Real Life Setting ◽

Actual Use ◽

Acuity Score

Introduction: Anti-vascular endothelial growth factor therapy has revolutionized the treatment of wet age-related macular degeneration; however, it is important to monitor actual use of ranibizumab and related treatment outcomes in routine practice.Material and Methods: This was a retrospective, observational study to monitor the 2-year outcomes following ranibizumab treatment for wet age-related macular degeneration in Portugal. Patients treated between January 2009 and December 2009 were retrospectively evaluated. All decisions were made by the treating physician in accordance with their usual routine clinical practice. The primary assessment was mean change in visual acuity score using Early Treatment Diabetic Retinopathy Study or Snellen equivalent.Results: A total of 128 patients with wet age-related macular degeneration were analyzed (mean age 79.4 years; mean visual acuity score 54.2 letters). Mean change in visual acuity score from baseline was –1.6 letters (n = 82) at year one and –5.1 letters (n = 72) at year two. The mean number of ranibizumab injections was 3.8 (year one) and 1.6 (year two). On average, patients attended 8.6 and 5.0 visits and optical coherence tomography was used in 75.0% of patients in year one and in 56.3% of patients in year two, respectively.Discussion: Despite a relatively high number of visits, including monitoring visits and use of optical coherence tomography - guided therapy, few injections were administered and visual acuity was not improved.Conclusion: These findings indicate that as-needed treatment resulted in under-dosing in a real-life setting in Portugal. Such limitations may also be related to increasing numbers of patients, resulting in clinic saturation.

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