Abstract

OBJECTIVESThe aim of this study was to evaluate the real-world incidence of endophthalmitis after intravitreal anti-vascular endothelial growth factor (VEGF) injections using data from the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).METHODSPatients with endophthalmitis that developed within 6 weeks after intravitreal anti-VEGF injections were identified in 3 large OMOP CDM databases.RESULTSWe identified 23,490 patients who received 128,123 intravitreal anti-VEGF injections. The incidence rates of endophthalmitis were 15.75 per 10,000 patients and 2.97 per 10,000 injections. The incidence rates of endophthalmitis for bevacizumab, ranibizumab, and aflibercept (per 10,000 injections) were 3.64, 1.39, and 0.76, respectively. The annual incidence has remained below 5.00 per 10,000 injections since 2011 despite the increasing number of intravitreal anti-VEGF injections. Bevacizumab presented a higher incidence rate for endophthalmitis than ranibizumab and aflibercept (incidence rate ratio, 3.17; p=0.021).CONCLUSIONSThe incidence of endophthalmitis after intravitreal anti-VEGF injections has stabilized since 2011 despite the explosive increase in anti-VEGF injections. The off-label use of bevacizumab accounted for its disproportionately high incidence of endophthalmitis. The OMOP CDM, which includes off-label uses, laboratory data, and a scalable standardized database, could provide a novel strategy to reveal real-world evidence, especially in ophthalmology.

Highlights

  • Anti-vascular endothelial growth factor (VEGF) drugs have revolutionized the treatment of causes of blindness, including age-related macular degeneration and diabetic retinopathy [1]

  • We considered anti-VEGF drugs prescribed by ophthalmologists as intravitreal injections since intravenous anti-VEGF drugs are used for chemotherapy

  • We analyzed data from 8,063,353 patients across the 3 Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) databases, from which we identified a total of 128,123 intravitreal anti-VEGF injections in 23,490 patients (12,726 males, 54.2%) (Table 2)

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Summary

Introduction

Anti-vascular endothelial growth factor (VEGF) drugs have revolutionized the treatment of causes of blindness, including age-related macular degeneration and diabetic retinopathy [1]. They play an essential therapeutic role in cases of retinal vein occlusion, neovascular glaucoma, and retinopathy of prematurity [2,3]. Several well-designed studies have shown the efficacy of anti-VEGF drugs for the aforementioned indications. Despite the efficacy and increased usage of these drugs, anti-VEGF agents have the potential risk of causing infectious endophthalmitis, sterile uveitis, retinal detachment, vitreous hemorrhage, and increased intraocular pressure [7]. Studies analyzing electronic health record (EHR) data, claims data, and real-world registries or databases have been reported [9,10]

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