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Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Diabetic Macular Edema: A “Real World” Analysis in 28,456 Eyes

Thomas A. Ciulla, MD, MBA


Thomas A. Ciulla, MD, MBA



  1. Midwest Eye Institute, Indianapolis IN

Purpose:  In diabetic macular edema (DME), few studies have investigated the translatability of randomized clinical trials (RCTs) to the “real world”, in which patients often do not meet RCT eligibility criteria, because of minimal or extensive systemic or ocular disease severity or both. This study assessed anti-vascular endothelial growth factor (VEGF) therapy intensity, as well as the relationship between treatment intensity and visual acuity (VA) outcomes, in “real world” DME patients, using a demographically diverse sample of U.S. retina specialists’ electronic medical records (EMR).

Methods: Analysis was performed on a large database of aggregated, longitudinal EMR from a demographically diverse sample of U.S. retina specialists. The HIPAA-compliant Vestrum Health Retina Database was used retrospectively. Treatment naïve DME patients who underwent anti-VEGF injections between January 2013 and October 2017 were eligible if follow up data was available through October 2018. VA outcomes were assessed at 1 year and stratified based on number of injections received over 1 year.

Results: This analysis included 28,456 eyes. The mean age at initial presentation was 62.5 years. At 1 year, the mean number of letters gained was 4 letters after a mean of 5.8 injections, with no significant trends in these figures between 2013-2017. There were no meaningful differences in injection frequency or visual outcomes based on choice of initial anti-VEGF agent.  Between 4 and 13 yearly injections, there was a linear relationship between number of injections over 1 year and mean letters gained. The mean change in VA at 1 year was +1.9, +4.2, +5.7, and +7.4 letters in those 2870, 3102, 2447, and 620 patients who received a mean of 3, 6, 9, and 12 injections respectively.

Conclusions: “Real world” DME patients are under-treated with resulting visual outcomes following anti-VEGF therapy less than those seen in randomized controlled trials. This analysis also demonstrates that treatment intensity in the “real world” correlates with visual outcomes over the first year of treatment.

Financial Disclosure: Thomas A Ciulla: Clearside Biomedical (employee, equity)