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

Not yet recruiting

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

• Registration Number: NCT06769412
• Lead Sponsor: Regeneron Pharmaceuticals

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

Study Timeline

• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-15
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 550000

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)

Key

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

NOTE: Other protocol defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aflibercept IVT Cohort	aflibercept 2 mg	Patients ≥ 18 years who initiated aflibercept 2 mg 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 6.5 years
Incidence of occlusive RV events confirmed through clinical chart abstraction	During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of non-occlusive RV events confirmed through clinical chart abstraction	During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of unconfirmed RV events	During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years