Skip to main content

  • Real-World Outcomes of Anti-VEGF for DME

    By Jean Shaw
    Selected By: Andrew P. Schachat, MD
    Add to My Bookmarks

    Journal Highlights

    Ophthalmology Retina, December 2018

    Download PDF

    Ciulla et al. set out to assess visual acuity (VA) outcomes in patients treated with anti–vascular endothelial growth factor (VEGF) for diabetic macular edema (DME). They found that in the “real world,” eyes with DME experienced worse visual outcomes and received slightly fewer anti-VEGF injections than did eyes enrolled in randomized controlled trials.

    For this retrospective population-based analysis, the researchers evalu­ated electronic health records from a demographically diverse sample of U.S. retina specialists. The treatment period spanned from January 2011 to March 2017. Eyes included in the study were those that had received at least 3 intravitreal injections within 4 months of the first injection and that had follow-up data available up to March 2018.

    Eyes (N = 15,608) were initially classified into 3 groups based on choice of anti-VEGF agent and then subdi­vided into 3 cohorts depending on length of follow-up. Primary outcome measures were VA and the number of treatments. Results were compared to those achieved in several randomized controlled trials, including the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol T study.

    For the entire study group at 12 months, eyes initiated on aflibercept, bevacizumab, and ranibizumab gained 5.5, 5.5, and 4.0 letters, respectively, compared with gains of 13.3, 9.7, and 11.2 letters for the same 3 agents in the Protocol T trial. With regard to the number of injections, the mean num­ber of injections at 12 months was 7.5, 7.9, and 7.7 for aflibercept, bevacizumab, and ranibizumab versus 9.2, 9.7, and 9.4, respectively, in Protocol T.

    When stratified by baseline VA, DME eyes with well-preserved VA (i.e., 20/40 or better at baseline) experienced some visual loss by month 12 despite treat­ment. Those initiated on aflibercept, bevacizumab, and ranibizumab lost 2.5, 2.0, and 2.7 letters, respectively. In con­trast, eyes in the Protocol T trial with a baseline VA of 20/40 or better gained 7.4, 6.0, and 6.1 letters with the same 3 agents at the 12-month mark.

    At 12 months, the real-world out­comes were inferior to those achieved in randomized controlled trials by approximately 1 line of VA for all eyes and 2 lines for eyes with a baseline VA of 20/40 or better. The results cannot be pinned entirely on undertreatment, as patient characteristics found outside of controlled trials—such as uncontrolled systemic comorbidities—will obviously play a role in real-world outcomes.

    The original article can be found here.