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

NCT06769412 | Completed

• 1 other identifier: VGFTe-OD-2457
• Study Type: observational
• Target: 550,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vasculitis

Keywords

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)

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Aflibercept IVT Cohort

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

Drug: aflibercept 2 mg

Interventions

aflibercept 2 mg DRUG

No study-specific investigations for this descriptive observational study

Also known as: Eylea®

Aflibercept IVT Cohort

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 to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR) without DME, DR with macular edema (ME) status unknown, or ME following retinal vein occlusion (RVO).

You may qualify if:

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

You may not qualify if:

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

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

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 10, 2025
• Study Start: July 1, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 1, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)