Long-term Treatment Patterns for Diabetic Macular Edema: Up to 6-Year Follow-up in the IRIS® Registry

Abstract

To characterize anti-vascular endothelial growth factor (VEGF) intravitreal therapy (IVT) patterns and long-term visual outcomes among patients with diabetic macular edema (DME) in routine clinical practice in the United States. Retrospective analysis of the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry.; Participants: Treatment-naïve patients with DME (no previous IVT in the past 12 months) initiating anti-VEGF IVT from 1/1/2015-3/31/2021. Baseline characteristics, treatment patterns, and long-term visual acuity (VA) outcomes were reported for up to 6 years of follow-up. Outcomes included the annualized number of injections, change in VA, and anti-VEGF agents. A total of 190,345 eyes met inclusion criteria. After 1 year of anti-VEGF IVT initiation, eyes received a mean of 3.9 (±2.8) injections and gained +3.2 (±16.4) letters of vision. Of the 1,236 eyes with year 6 data, eyes received a mean of 2.9 (±2.1) injections in year 6 and gained +0.5 (±19.7) letters from baseline. The number of injections decreased, and injection intervals increased year over year up to 6 years regardless of baseline VA initiation. The average injection interval was 10-weeks in year 1, then widened to 13.2 in year 2, before plateauing in years 3-6 (12.6, 12.3, 12.2, and 12.3 weeks respectively). Improvements in VA from baseline were greatest in eyes that received 5 or more injections each year. At the end of follow-up, eyes with good baseline vision (> 20/25) lost vision, whereas those with worse baseline vision (< 20/25) gained vision. Although 51.7% of patients with DME discontinued IVT after a mean of 6 months, 32.8% re-initiated anti-VEGF IVT. Worse VA outcomes were associated with patients of Hispanic ethnicity (-1.08 [-1.34, -0.83] compared to non-Hispanic), Medicaid insurance (-1.15 [-1.48, -0.81] compared to Commercial), and older age (-0.06 [-0.07, -0.05] each additional year) CONCLUSIONS: Patients with DME in the routine clinical settings receive fewer injections than those in clinical trials and fewer than recommended per the label of FDA approved anti-VEGF IVT.