Effect of intravitreal aflibercept on recalcitrant diabetic macular edema

Kendra A Klein,Elias Reichel,Tina S Cleary

doi:10.1186/s40942-017-0064-0

Abstract

Background Despite anti-VEGF therapy, some patients develop chronic diabetic macular edema. The objective of this study was to evaluate anatomic and visual outcomes of switching patients with chronic DME from intravitreal bevacizumab or ranibizumab to intravitreal aflibercept injection.MethodsIn this retrospective observational case series, 11 eyes with recalcitrant diabetic macular edema (DME) were evaluated 6 months prior to and 6 months following initial intravitreal aflibercept injection (IAI). Recalcitrant DME was defined as having a thickened retina (≥350 μm) on spectral domain optical coherence tomography (SD-OCT) with persistent cystic changes (less than a 15% reduction in central retinal thickness) over 6 months prior to intravitreal aflibercept switch despite aggressive treatment for DME during this time.ResultsOne hundred and forty-seven patients in total were treated with IAI during this time, and of these, 31 patients were treated with IAI for DME. 18 eyes had less than 4 treatments within the 6 months prior to switch to IAI, 6 patients had a central retinal thickness (CRT) on SD-OCT of less than 350 μm at time of switch to IAI, and 2 patients had a greater than 15% decline in CRT on SD-OCT over the 6 months prior to switch to IAI. A total of 11 patients were included in the study. Over the 6 months prior to switch, the mean change in central retinal thickness was +18.6% and over the 6 months following switch to aflibercept the mean change in central retinal thickness was −27.1%. Switching to a regimen of at least 3 intravitreal aflibercept injections over 6 months resulted in some anatomic improvement and improvement or stabilization of Snellen visual acuity in all eligible patients.ConclusionsIn patients with recalcitrant diabetic macular edema, switching to intravitreal aflibercept resulted in improved a 25% or more decrease in central retinal thickness in 81% (9/11) patients at 6-month follow-up. Sixty-three percent (7/11) had improvement in Snellen visual acuity after switching to intravitreal aflibercept injection, suggesting some reversibility of functional damage.

Highlights

Despite anti-vascular endothelial growth factor (VEGF) therapy, some patients develop chronic diabetic macular edema
Intravitreal ranibizumab (Lucentis; Genentech, San Francisco, California) became the first VEGF inhibitor Food and Drug Administration (FDA)-approved for the treatment of Diabetic macular edema (DME) in 2012 following the RIDE and RISE trials, which showed significant superiority of both 0.3 and 0.5 mg ranibizumab groups over sham injection in improving visual acuity and decreasing central retinal thickness in patients with DME
We evaluated the outcome of switching to aflibercept (IAI) in patients with DME considered to be “recalcitrant” to therapy

Summary

Introduction

Despite anti-VEGF therapy, some patients develop chronic diabetic macular edema. The objective of this study was to evaluate anatomic and visual outcomes of switching patients with chronic DME from intravitreal bevacizumab or ranibizumab to intravitreal aflibercept injection. Better understanding of the Intravitreal ranibizumab (Lucentis; Genentech, San Francisco, California) became the first VEGF inhibitor FDA-approved for the treatment of DME in 2012 following the RIDE and RISE trials, which showed significant superiority of both 0.3 and 0.5 mg ranibizumab groups over sham injection in improving visual acuity and decreasing central retinal thickness in patients with DME. In July 2014, the FDA approved intravitreal aflibercept (Eylea; Regeneron, Tarrytown, New York), a highly specific fusion protein with high VEGF-binding affinity, for the treatment of DME. This approval followed the VIVID and VISTA clinical trials, which showed superiority in anatomic and visual outcomes in patients treated with intravitreal aflibercept in comparison to laser treated controls. Patients in these studies required a 3-month washout period for patients previously treated with antiVEGF agents [9]

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