RECRUITING

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

Conditions

Retinal Vasculitis Anti-vascular endothelial growth factor Aflibercept Neovascular age-related macular degeneration (nAMD)Diabetic macular edema (DME)Diabetic retinopathy (DR) without macular edema (ME)Diabetic retinopathy (DR) with macular edema (ME)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry

Quick Facts

Study Start:2025-07-01

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06769412

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Contact

Clinical Trials Administrator

CONTACT

844-734-6643

clinicaltrials@regeneron.com

Study Locations (Sites)

Regeneron Research Site

Tarrytown, New York, 10591

United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2025-07-01

Study Completion Date2025-09-01

Terms related to this study

Keywords Provided by Researchers

Anti-vascular endothelial growth factor
Aflibercept
Neovascular age-related macular degeneration (nAMD)
Diabetic macular edema (DME)
Diabetic retinopathy (DR) without macular edema (ME)
Diabetic retinopathy (DR) with macular edema (ME)

Additional Relevant MeSH Terms

Retinal Vasculitis