Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study

Completed

• Conditions: Retinal Vasculitis
• Interventions: Drug: aflibercept 2mg

• Registration Number: NCT07105228
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2025-07-08
• Study Start: 2025-07-15
• Study First Submitted QC: 2025-07-29
• Study First Posted: 2025-08-05
• Primary Completion: 2025-08-30
• Status Verified: 2025-09
• Study Completion: 2025-09-15
• Last Update Submitted: 2025-10-09
• Last Update Posted: 2025-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290000

Inclusion Criteria

Not provided

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/Exclusion Criteria Apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Patients	aflibercept 2mg	Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period

Primary Outcome Measures

Name	Time	Method
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
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 \[MEfRVO\])
Demographics characteristics	12 months prior to the index date	Demographics include: sex, age, race/ethnicity, insurance, geographic area
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
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
Clinical characteristics: Number of participants with prior anti-VEGF treatment	12 months prior to the index date

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Regeneron Research Site; 🇺🇸 Tarrytown, New York, United States