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

Abstract

Objective: To characterize anti-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.

Design: Retrospective analysis of the American Academy of Ophthalmology's IRIS® (Intelligent Research in Sight) Registry.

Participants: Treatment-naïve patients with DME (no previous IVT in the past 12 months) initiating anti-VEGF IVT from January 1, 2015, to March 31, 2021.

Methods: Baseline characteristics, treatment patterns, and long-term visual acuity (VA) outcomes were reported for up to 6 years of follow-up.

Main outcome measures: Outcomes included the annualized number of injections, change in VA, and anti-VEGF agents.

Results: A total of 190 345 eyes met the 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 1236 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 and increased to 13.2 weeks in year 2 before plateauing in years 3 to 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% reinitiated anti-VEGF IVT. Worse VA outcomes were associated with patients of Hispanic ethnicity (-1.08; 95% confidence interval: -1.34, -0.83] compared with non-Hispanic), Medicaid insurance (-1.15; 95% confidence interval: -1.48, -0.81 compared with commercial), and older age (-0.06; 95% confidence interval: -0.07, -0.05] each additional year).

Conclusions: Patients with DME in routine clinical settings receive fewer injections than those in clinical trials and fewer than recommended per the label of US Food and Drug Administration-approved anti-VEGF IVT.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.

Keywords: Anti-VEGF injections; Diabetic macular edema; Routine clinical practice; Visual outcomes.