Retinal Vasculitis
Conditions
Keywords
Anti-Vascular Endothelial Growth Factor (VEGF), Aflibercept, neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema Following Retinal Vein Occlusion (RVO)
Brief summary
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.
Detailed description
This study is purely descriptive using US claims data from Komodo Healthcare Map.
Interventions
DRUGaflibercept 2mg
No study-specific interventions administered in this observational study
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Aflibercept injections with unspecified laterality will be excluded 2. Aflibercept injections from individuals aged \<18 years or those with unknown age on the injection date will be excluded 3. Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol 4. Patient-eyes that do not meet the continuous enrollment requirement will be excluded 5. Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same date NOTE: Other Protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics: Number of participants with prior anti-VEGF treatment | 12 months prior to the index date | — |
| Clinical characteristics: Summary of comorbidities reported as number of participants with different categories | 12 months prior to the index date | Different comorbidity categories: Syphilis, Herpesviridae, Toxoplasmosis, Tuberculosis, Systemic lupus erythematosus, Multiple sclerosis, Behçet's disease, Cardiovascular disease, Hypertension, Diabetes, Hypercholesterolemia |
| Incidence of RV events | During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years | 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 |
| Incidence of RV plus IOI events | During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years | 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 |
| Demographics characteristics | 12 months prior to the index date | Demographics include: sex, age, race/ethnicity, insurance, geographic area |
| Clinical characteristics: Number of participants with different retinal disease diagnosis categories | 12 months prior to the index date | Retinal disease categories: nAMD, DME, DR w/o DME, or macular edema following retinal vein occlusion \[MEfRVO\]) |
| Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score | 12 months prior to the index date | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of RV plus RO | During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years | 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 |
Countries
United States
Outcome results
None listed