Anti-vascular endothelial growth factor (VEGF) therapy does not increase the risk of systemic serious adverse events in patients with diabetic macular edema (DME) compared with patients treated with macular laser photocoagulation or intravitreal corticosteroid, according to a recent real-world analysis of patients in a large U.S. insurance database.1
“It is increasingly evident that these medications are well tolerated systemically when delivered as intravitreal pharmacotherapy for sight-threatening retinal disease, including in the real-world treatment of DME,” the study authors wrote.
Maloney et al. conducted a large retrospective cohort study of more than 23,000 patients with DME spanning more than a decade and found no differences in increased risk of myocardial infarction, cerebrovascular disease (e.g., stroke, systemic embolism, transient ischemic attack), or major bleeding (gastrointestinal or intracranial bleeding, as well as bleeding from other sites) in patients treated with anti-VEGF versus those treated with steroids or laser therapy, regardless of which anti-VEGF is used.1
DME, a complication of diabetes, is a leading cause of vision loss in the United States, impacting more than 746,000 people over age 40, Maloney et al. wrote. Due to the rising rate of diabetes, the number of people with DME is expected to increase. It is estimated that 592 million people will have DME by 2035, an expected increase of 55% from 2013.2
As of 2016, more than 90% of retinal specialists in the United States treat DME patients with anti-VEGF therapy (aflibercept, ranibizumab, or off-label bevacizumab).3
The efficacy of anti-VEGF therapy for DME has been well established in multiple clinical trials, and reported systemic serious adverse events (SAEs) have been low.4,5
In fact, a meta-analysis of these studies has found them underpowered to evaluate for potentially significant differences in systemic SAEs.1 As treatment patterns in the clinic often differ substantially from those within clinical trials, this retrospective analysis of real-world patients is particularly important given the expected rise in patients who will need treatment.
1. Maloney MH, Schilz SR, Herrin J, et al. Risk of Systemic Adverse Events Associated with Intravitreal Anti-VEGF Therapy for Diabetic Macular Edema in Routine Clinical Practice. Ophthalmology. 2019;126(7):1007-15.
2. Guariguata L, Whiting DR, Hambleton I, et al. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014;103(2):137-49.
3. American Society of Retina Specialists ST. ASRS 2016 Preferences and Trends Membership Survey. Chicago, IL: American Society of Retina Specialists., 2016.
4. Brown DM, Nguyen QD, Marcus DM, et al. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology. 2013;120(10):2013-22.
5. Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care. 2010;33(11):2399-405.