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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Patients | Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept 2mg | Drug | No study-specific interventions administered in this observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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]) | 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 | 12 months prior to the index date |
| Clinical characteristics: Summary of comorbidities reported as number of participants with different categories |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years |
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Inclusion Criteria for Patient Population:
1. All aflibercept injections identified by the Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) from January 1, 2017, to February 29, 2024, as recorded in the Komodo close claims database.
Key Exclusion Criteria:
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
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The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | Tarrytown | New York | 10591 | United States |
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| ID | Term |
|---|---|
| D031300 | Retinal Vasculitis |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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Different comorbidity categories: Syphilis, Herpesviridae, Toxoplasmosis, Tuberculosis, Systemic lupus erythematosus, Multiple sclerosis, Behçet's disease, Cardiovascular disease, Hypertension, Diabetes, Hypercholesterolemia |
| 12 months prior to the index date |
| Clinical characteristics: Number of participants with prior anti-VEGF treatment | 12 months prior to the index date |
| D002318 |
| Cardiovascular Diseases |
| D003925 | Diabetic Angiopathies |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |