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

NCT07105228 | Completed

• 1 other identifier: VGFTe-OD-2458
• Study Type: observational
• Target: 290,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vasculitis

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)

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (1)

• Incidence of RV plus RO

  During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years

Study Arms (1)

Study Patients

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

Drug: aflibercept 2mg

Interventions

aflibercept 2mg DRUG

No study-specific interventions administered in this observational study

Also known as: Eylea®

Study Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Research Site

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Retinal Vasculitis; Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 5, 2025
• Study Start: July 15, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 15, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-09

Locations

US (1)