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OpenTrials
Completed

NCT Number: NCT07105228

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

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.

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Key information

Conditions

Retinal Vasculitis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Research Site

Tarrytown, New York, 10591, United States

About this study

This study is purely descriptive using US claims data from Komodo Healthcare Map.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patient Population:

  • 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:

  • Aflibercept injections with unspecified laterality will be excluded
  • Aflibercept injections from individuals aged <18 years or those with unknown age on the injection date will be excluded
  • 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
  • Patient-eyes that do not meet the continuous enrollment requirement will be excluded
  • 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

Treatment and study plan

Aflibercept 2mg

Drug

No study-specific interventions administered in this observational study

Other names: Eylea®

Primary outcomes

  1. Incidence of RV events

    Time frame: 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

  2. Incidence of RV plus IOI events

    Time frame: 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

  3. Demographics characteristics

    Time frame: 12 months prior to the index date

    Demographics include: sex, age, race/ethnicity, insurance, geographic area

  4. Clinical characteristics: Number of participants with different retinal disease diagnosis categories

    Time frame: 12 months prior to the index date

    Retinal disease categories: nAMD, DME, DR w/o DME, or macular edema following retinal vein occlusion [MEfRVO])

  5. Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score

    Time frame: 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

  6. Clinical characteristics: Summary of comorbidities reported as number of participants with different categories

    Time frame: 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

  7. Clinical characteristics: Number of participants with prior anti-VEGF treatment

    Time frame: 12 months prior to the index date

Secondary outcomes

  1. Incidence of RV plus RO

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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