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AFLIBERCEPT FOR PERSISTENT DIABETIC MACULAR EDEMA: Forty-Eight–Week Outcomes

Bahrami, Bobak, MBBS*,†; Hong, Thomas, PhD*; Schlub, Timothy E., BSc (Hons), PhD; Chang, Andrew A., FRANZCO, PhD*,†

doi: 10.1097/IAE.0000000000002253
Original Study: PDF Only

Purpose: To evaluate functional and anatomical outcomes after a switch from intravitreal bevacizumab to aflibercept in patients with persistent diabetic macular edema.

Methods: Prospective, single-arm, open-label clinical trial of patients with persistent diabetic macular edema, despite previous treatment with bevacizumab. Five loading doses of intravitreal aflibercept were administered every 4 weeks with subsequent injections administered every 8 weeks. Patients were reviewed every 4 weeks, and best-corrected visual acuity and central macular thickness were recorded. Primary outcome measures included change in central macular thickness and best-corrected visual acuity at week 48 compared with baseline. Paired t-tests were used to assess change between baseline and follow-up visits.

Results: At baseline, 43 eyes from 43 patients were recruited with a median (interquartile range) of 12 (7–24) previous intravitreal anti–vascular endothelial growth factor injections over a period of 18 (8–34) months. Mean ± SD central macular thickness reduced by 59 ± 114 μm (P = 0.002), and best-corrected visual acuity improved by 3.9 ± 7.0 letters (P = 0.001) after 48 weeks in the 41 patients who completed the trial. Best-corrected visual acuity improvements were more marked in patients who gained ≥5 letters after the first injection (8.9 ± 5.7 vs. 1.8 ± 6.5 letter gain at 48 weeks, P = 0.002), a difference which remained significant after regression analysis with baseline best-corrected visual acuity . Vision gains and central macular thickness reduction were similar in 9 fellow eyes eligible for inclusion being concurrently treated for diabetic macular edema with bevacizumab.

Conclusion: Intravitreal aflibercept was effective in improving anatomical and visual outcomes among patients with an incomplete response to intravitreal bevacizumab with 48 weeks of follow-up. Patients with a good early response subsequent to switching had a better improvement in vision at 48 weeks.

Over a 48-week treatment period, intravitreal aflibercept is effective in reducing central macular thickness and improving vision in patients with persistent diabetic macular edema incompletely responsive to intravitreal bevacizumab.

*Sydney Institute of Vision Science/Sydney Retina Clinic and Day surgery, New South Wales, Australia;

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

Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.

Reprint requests: Andrew Chang, FRANZCO, PhD, Sydney Retina Clinic and Day Surgery, 13/187 Macquarie Street, Sydney, New South Wales 2000, Australia; e-mail: achang@sydneyretina.com.au

Supported by Bayer Corporation Global. The sponsor had no role in the design, conduct, or analysis of this research.

Preliminary data from this work were presented at the Association for Research in Vision and Ophthalmology Annual Meeting, Baltimore, MD, May 7, 2017; the Royal Australian College of Ophthalmologists Annual Congress, Melbourne, Australia, November 21, 2016; and the Association for Research in Vision and Ophthalmology Annual Meeting, Seattle, WA, May 2, 2016.

None of the authors has any financial/conflicting interests to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).

A. Chang has acted as a consultant for Bayer, Allergan, and Novartis. B. Bahrami is supported by The University of Sydney Postgraduate Award.

© 2018 by Ophthalmic Communications Society, Inc.