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Barthelmes, Daniel, MD, PhD*,†; Nguyen, Vuong, PhD; Daien, Vincent, MD, PhD†,‡; Campain, Anna, PhD; Walton, Richard, MSc; Guymer, Robyn, MBBS, PhD§; Morlet, Nigel, MBBS; Hunyor, Alex, P., MBBS†,**; Essex, Rohan, W., MBBS††; Arnold, Jennifer, J., MBBS (Hons)‡‡; Gillies, Mark, C., MBBS, PhDthe Fight Retinal Blindness Study Group

doi: 10.1097/IAE.0000000000001496
Original Study

Purpose: To report 24-month outcomes of a treat and extend (T&E) regimen using aflibercept in eyes with neovascular age-related macular degeneration.

Methods: This was a database observational study that included treatment-naive eyes with neovascular age-related macular degeneration tracked by the Fight Retinal Blindness! outcome registry completing 24 months of sole monotherapy with aflibercept treatment under a T&E regimen between November 1, 2012 and January 31, 2014. Locally weighted scatterplot smoothing curves were used to display visual acuity outcomes. Main outcome measures were change in visual acuity at 24 months and number of injections and visits during the study period.

Results: The study population, identified by reviewing the database, consisted of 136 eyes from 123 patients completing 24 months of follow-up on aflibercept. Mean (SD) age was 77.2 (7.0) years, 59% were female. Mean visual acuity increased from 61.4 (∼20/60; SD 17.4) letters at baseline to 67.4 (∼20/45; SD 17.7) letters at 24 months (+6.0 letters [95% confidence interval: 3.3–8.5]; P < 0.001). From baseline to 24 months, the proportion of eyes with visual acuity ≥70 letters (20/40) increased (40%–58%, P < 0.001) and the proportion of eyes with visual acuity ≤35 letters (20/200) remained the same (10%; P = 0.547). Ninety-eight per cent of eyes starting with visual acuity ≥70 letters (20/40) were able to maintain this up to 24 months. From the first to the second year of treatment, the mean number of injections (7.8 [2.1] vs. 5.7 [2.6]; P < 0.001) and visits (8.7 [1.7] vs. 6.5 [2.4]; P < 0.001) decreased for eyes completing 24 months of treatment. When data from 60 eligible eyes that did not complete 2 years follow-up, along with 14 eyes that switched to ranibizumab, were included using last observation carried forward, the mean change in visual acuity from baseline was +5.6 letters (95% confidence interval: 3.3–7.7).

Conclusion: These data indicate that eyes treated with aflibercept, as a sole therapy, in routine clinical practice with a T&E regimen can achieve good visual outcomes while decreasing the burden of treatments and clinic visits.

Twenty-four months after starting therapy, a mean improvement of six logMAR letters was found in this analysis of eyes with neovascular age-related macular degeneration treated with aflibercept monotherapy under a treat and extend regimen.

*Department of Ophthalmology, University Hospital Zurich, University of Zurich, Zurich, Switzerland;

The Save Sight Institute, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia;

Montpellier University Hospital, Montpellier, France;

§Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Victoria, Australia;

Department of Population Health, University of Western Australia, Perth, Western Australia;

**Retina Associates, Chatswood, New South Wales, Australia;

††Academic Unit of Ophthalmology, Australian National University, Acton, Australian Capital Territory, Australia; and

‡‡Marsden Eye Specialists, Parramatta, New South Wales, Australia.

Reprint requests: Daniel Barthelmes, MD, PhD, Department of Ophthalmology, University Hospital Zurich, Frauenklinikstrasse 24, Zurich 8091, Switzerland; e-mail:

Supported by a grant from the Royal Australian NZ College of Ophthalmologists Eye Foundation (2007–2009) and a grant from the National Health and Medical Research Council, Australia (NHMRC 2010–2012).

M. C. Gillies is a Sydney Medical Foundation Fellow and is supported by an NHMRC practitioner fellowship, and R. Guymer is supported by a NHMRC Principal research fellowship. D. Barthelmes was supported by the Walter and Gertrud Siegenthaler Foundation Zurich, Switzerland and the Swiss National Foundation. Funding was also provided by Novartis and Bayer. These supporting organizations had no role in the design or conduct of the research. M. C. Gillies and R. Guymer are members of advisory boards for Novartis and Bayer. D. Barthelmes received research grants from Novartis and Bayer. V. Daien received travel grants from Novartis and Bayer. None of the other authors have no any conflicting interests to disclose.

© 2018 by Ophthalmic Communications Society, Inc.