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Real-world Outcomes of Anti–Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema in the United States

      Highlights

      • Precis: This population-based analysis of anti-VEGF use in patients with diabetic macular edema demonstrates that patients on average receive fewer injections over 12 months and have meaningfully worse visual acuity outcomes compared to randomized controlled trials.

      Purpose

      This study assessed real-world visual acuity (VA) outcomes of anti–vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME).

      Design

      This retrospective analysis was performed on a large database of aggregated, longitudinal electronic medical records from a geographically and demographically diverse sample of patients of United States retina specialists (Vestrum Health Retina Database).

      Participants

      DME patient eyes that underwent ≥3 monthly anti-VEGF injections within 4 months of the first injection and between January 2011 and March 2017 were eligible if follow-up data were available prior to March 2018.

      Methods

      The eyes were divided into 3 groups based on choice of initial intravitreal anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab). These eyes were then subdivided into 3 cohorts, depending on length of follow-up (6, 12, or 24 months), with each cohort being mutually exclusive.

      Main Outcome Measures

      VA outcomes and number of treatments were assessed on each cohort and stratified by baseline VA.

      Results

      A total of 15,608 DME patient eyes were included in this analysis. In the 12-month cohort, of 1379 eyes initially treated with aflibercept, the mean 12-month improvement was +5.5 letters (95% confidence interval [CI] +4.5 to +6.6 letters, P < 0.001) after 7.5 injections on average, with similar outcomes for bevacizumab (3109 eyes, +5.5 letters, 95% CI +4.7 to +6.3 letters, P < 0.001, average 7.9 injections), and for ranibizumab (1352 eyes, +4.0 letters, 95% CI +2.9 to +5.2 letters, P < 0.001, average 7.7 injections). The mean numbers of corticosteroid, macular, and panretinal laser treatment sessions were similar in each group. In the 12-month cohort, when stratified by baseline VA of 20/201 or worse, 20/71 to 20/200, 20/41 to 20/70, and 20/40 or better, the final mean letters gained or lost were +28.0, +10.2, +2.8, and −2.5 in the aflibercept group, +36.0, +7.8, +2.9, and −2.0 letters in the bevacizumab group, and +30.5, +7.9, +1.6, and −2.7 letters in the ranibizumab group, respectively.

      Conclusions

      Real-world VA outcomes following anti-VEGF therapy for DME were meaningfully inferior to those noted in randomized, controlled trials. Eyes with better baseline VA experienced fewer letters gained compared with those with worse baseline VA. The initial choice of anti-VEGF agent did not correlate with visual outcomes.

      Abbreviations and Acronyms:

      anti-VEGF (antievascular endothelial growth factor), B (bevacizumab), BCVA (best-corrected visual acuity), DRCR (Diabetic Retinopathy Clinical Research Network), ERM (epiretinal membrane), ETDRS (Early Treatment Diabetic Retinopathy Study), OCT (optical coherence tomography), PDR (proliferative diabetic retinopathy), R (ranibizumab), RIDE (A Study of Ranibizumab Injection in Participants with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus), RISE (A Study of Ranibizumab Injection in Participants with Clinical Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus), VA (visual acuity), VEGF (vascular endothelial growth factor), VISTA (Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema), VIVID (Intravitreal Aflibercept Injection in Vision Impairment Due to Diabetic Macular Edema), VMT (vitreomacular traction)
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