Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)

Abstract

Purpose

To evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF) inhibitors as used in clinical practice for the treatment of diabetic macular edema.

Methods

Multicenter (10 sites), retrospective chart review in patients (n=156) who received ≥3 anti-VEGF injections. Data collected for ≥6 months after the first injection included Snellen best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by time-domain or spectral-domain optical coherence tomography (TD-OCT or SD-OCT).

Results

Mean number of anti-VEGF injections (627 bevacizumab, 594 ranibizumab, 1 aflibercept) was 5.8 (year 1), 5.0 (year 2), and 3.4 (year 3). Percentage of patients with BCVA of 20/40 or better and CRT ≤250 μm on TD-OCT or ≤300 μm on SD-OCT at the same visit (primary endpoint) ranged from 16.4% to 38.9% after the first 10 injections; 51.9%–62.3% achieved ≥20/40 BCVA and 26.2%–48.0% met CRT criteria. Therapy was well tolerated with 19 treatment-related adverse events (all ocular) reported.

Conclusion

Anti-VEGF injections were administered less frequently and were less effective than those in the ranibizumab registration trials. After each of the first 9 injections, <25% of patients achieved both BCVA of 20/40 or better and a dry macula. A substantial proportion of patients are suboptimal responders to anti-VEGF therapy; these patients may be candidates for other therapies, including intravitreal corticosteroid and laser therapy.

Keywords:

• bevacizumab
• diabetic retinopathy
• drug administration schedule
• ranibizumab
• vascular endothelial growth factor
• visual acuity

Acknowledgments

This study was sponsored by Allergan plc, Dublin, Ireland. A contract research organization, Trial Runners, LLC (Dickinson, ND, USA), was responsible for project and data management and performed the statistical analysis of the data. Writing and editorial assistance was provided to the authors by Kate Ivins, PhD, Evidence Scientific Solutions, Philadelphia, PA, USA, and funded by Allergan plc. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. This study was presented in part at the American Society of Retina Specialists (ASRS) Annual Meeting, Vienna, Austria, July 12, 2015. ECHO Study Group Principal Investigators are as follows: Kevin J Blinder, MD (St Louis, MO, USA); David S Boyer, MD (Beverly Hills, CA, USA); Antonio Capone Jr, MD (Royal Oak, MI, USA); Sanford Chen, MD (Santa Ana, CA, USA); Pravin Dugel, MD (Phoenix, AZ, USA); J Michael Jumper, MD (San Francisco, CA, USA); Alan Margherio, MD (Grand Rapids, MI, USA); Joel Pearlman, MD (Sacramento, CA, USA); Michael A Singer, MD (San Antonio, TX, USA).

Disclosure

The authors have no proprietary interest in this work. Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. KJ Blinder is a consultant to Allergan, Bausch + Lomb, Dutch Ophthalmics, Genentech, Regeneron, Synergetics, and Thrombogenics and has received lecture fees from Allergan, Bausch + Lomb, Regeneron, Synergetics, and Thrombogenics. PU Dugel is a consultant to Allergan and has received research grants from Allergan. S Chen is a consultant to Alcon, Alimera, Allergan, Genentech, and Regeneron. JM Jumper is a clinical investigator for Allergan, Genentech, Ophthotech, and Regeneron and has received research grants from Allergan. JG Walt is an employee of Allergan. DA Hollander and LC Scott are former employees of Allergan. The authors report no other conflicts of interest in this work.