An observational study in Retinal Vasculitis, sponsored by Regeneron Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Regeneron Pharmaceuticals · Observational
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.
773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's enrollment of 290,000 is above the median of 154 across 264 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
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The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections
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
Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period
Drug: aflibercept 2mg
No study-specific interventions administered in this observational study
Also known as: Eylea®
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
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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Retinal Vasculitis
Regeneron Pharmaceuticals