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

NCT ID: NCT07105228

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-09-15

Brief Summary

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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

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

Conditions

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Retinal Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study Patients

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

aflibercept 2mg

Intervention Type DRUG

No study-specific interventions administered in this observational study

Interventions

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aflibercept 2mg

No study-specific interventions administered in this observational study

Intervention Type DRUG

Other Intervention Names

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Eylea®

Eligibility Criteria

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Inclusion Criteria

1\. 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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Research Site

Tarrytown, New York, United States

Site Status

Countries

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United States

Other Identifiers

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VGFTe-OD-2458

Identifier Type: -

Identifier Source: org_study_id

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