CompletedNot Applicable

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

United States550,000 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

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

What they're measuring

Incidence of RV events

Timeframe: 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

Timeframe: 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

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

Incidence of unconfirmed RV events

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

Trial details

NCT IDNCT06769412

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-15

View on ClinicalTrials.gov More Retinal Vasculitis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

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

What they're measuring

Incidence of RV events

Timeframe: 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

Timeframe: 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

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

Incidence of unconfirmed RV events

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