| Summary: | Andrew Moshfeghi,1 Vincent Garmo,2 Daniel Sheinson,2 Avanti Ghanekar,2 Ibrahim Abbass2 1USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 2Genentech, Inc., South San Francisco, CA, USACorrespondence: Andrew MoshfeghiUSC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine, University of Southern California, 1450 San Pablo Street, Suite 4700, Los Angeles, CA 90033, USATel +1 323 442 6335Fax +1 323 442 6410Email moshfega@med.usc.eduPurpose: To characterize the natural course of diabetic retinopathy (DR) in contemporary clinical practice.Patients and Methods: This was a retrospective analysis of US claims data collected between January 1, 2006, and April 30, 2017. Patients aged ≥ 18 years with continuous medical and prescription insurance coverage for 18 months before DR diagnosis (index date) and for a follow-up period of 5 years were included (N=14,490). The time and risk of progressing to severe nonproliferative DR (NPDR) or proliferative DR (PDR) and of developing diabetic macular edema (DME) were evaluated over 5 years in patients stratified by DR severity at initial diagnosis.Results: The estimated probability of progressing to severe NPDR or PDR within 5 years of diagnosis was 17.6% for patients with moderate NPDR versus 5.8% for mild NPDR. The probability of developing DME within 5 years was 62.6%, 44.6%, and 28.4% for patients diagnosed with severe NPDR, moderate NPDR, and PDR, respectively, versus 15.6% for mild NPDR. Among those observed to progress, median time to severe NPDR or PDR was approximately 2.0 years in patients with moderate NPDR, whereas median time to DME was approximately 0.5 years in patients with severe NPDR, 1.3 years in moderate NPDR, and 1.6 years in PDR. Relative to mild NPDR, adjusted hazard ratios (95% confidence interval) for progression to severe NPDR or PDR within 5 years were 3.12 (2.61– 3.72) in patients with moderate NPDR, and for incident DME were 5.92 (5.13– 6.82), 3.54 (3.22– 3.91), and 1.96 (1.80– 2.14) in patients with severe NPDR, moderate NPDR, and PDR, respectively.Conclusion: The risk of DR progression and DME over 5 years was highest among patients diagnosed with moderate and severe NPDR, respectively. Our findings reinforce the importance of close monitoring for these patients to avoid unobserved disease progression toward PDR and/or DME.Keywords: diabetic macular edema, diabetic retinopathy, disease progression, real-world evidence
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