A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)

NCT ID: NCT06769412

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 550000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-09-01

Brief Summary

This study will describe and estimate the incidence of RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 2mg) therapy in US clinical practice. This study will also use clinical record review to confirm cases of RV first identified using International Classification of Diseases, tenth revision, Clinical Modification (ICD-10-CM) codes and to identify RV with occlusion.

Detailed Description

This study is purely descriptive using secondary data from the Verana Health Retinal Outcomes module sourced from the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry

Conditions

Retinal Vasculitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Aflibercept IVT Cohort

Patients ≥ 18 years who initiated aflibercept 2 mg IVT during the study period

aflibercept 2 mg

Intervention Type: DRUG

No study-specific investigations for this descriptive observational study

Interventions

aflibercept 2 mg

No study-specific investigations for this descriptive observational study

Intervention Type: DRUG

Other Intervention Names

Eylea®

Eligibility Criteria

Inclusion Criteria

1. Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023

2. Patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. The earliest date of aflibercept injection will be the index date for each patient-eye

3. Patient-eyes with diagnosis (documented through ICD-10-CM diagnosis code) of nAMD, DME, DR without DME, DR with ME status unknown, and/or ME following RVO in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive)

Exclusion Criteria

1. Patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol

2. 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

3. Aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Regeneron Research Site

Tarrytown, New York, United States

Countries

United States

Other Identifiers

VGFTe-OD-2457

Identifier Type: -

Identifier Source: org_study_id