This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice. The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.
This study is purely descriptive using US claims data from Komodo Healthcare Map.
Study Type
OBSERVATIONAL
Enrollment
290,000
No study-specific interventions administered in this observational study
Regeneron Research Site
Tarrytown, New York, United States
Incidence of RV events
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Incidence of RV plus IOI events
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Demographics characteristics
Demographics include: sex, age, race/ethnicity, insurance, geographic area
Time frame: 12 months prior to the index date
Clinical characteristics: Number of participants with different retinal disease diagnosis categories
Retinal disease categories: nAMD, DME, DR w/o DME, or macular edema following retinal vein occlusion \[MEfRVO\])
Time frame: 12 months prior to the index date
Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score
The Charlson Comorbidity Index (CCI) is a method used to categorize comorbidities based on International Classification of Diseases (ICD) diagnosis codes. A score of 0 indicates that no comorbidities were found, while higher scores correspond to increased predicted mortality
Time frame: 12 months prior to the index date
Clinical characteristics: Summary of comorbidities reported as number of participants with different categories
Different comorbidity categories: Syphilis, Herpesviridae, Toxoplasmosis, Tuberculosis, Systemic lupus erythematosus, Multiple sclerosis, Behçet's disease, Cardiovascular disease, Hypertension, Diabetes, Hypercholesterolemia
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Time frame: 12 months prior to the index date
Clinical characteristics: Number of participants with prior anti-VEGF treatment
Time frame: 12 months prior to the index date
Incidence of RV plus RO
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years