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OpenTrials
Completed

NCT Number: NCT06769412

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

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.

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Key information

Conditions

Retinal Vasculitis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Research Site

Tarrytown, New York, 10591, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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)

Key Exclusion Criteria:

  • 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

NOTE: Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

Aflibercept 2 mg

Drug

No study-specific investigations for this descriptive observational study

Other names: Eylea®

Primary outcomes

  1. Incidence of RV events

    Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years

  2. Incidence of occlusive RV events confirmed through clinical chart abstraction

    Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years

  3. Incidence of non-occlusive RV events confirmed through clinical chart abstraction

    Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years

  4. Incidence of unconfirmed RV events

    Time frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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