CompletedNot Applicable

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

United States290,000 participantsStarted 2025-07-15

Plain-language summary

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.

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.

Exclusion criteria

✕. Aflibercept injections with unspecified laterality will be excluded
✕. Aflibercept injections from individuals aged \<18 years or those with unknown age on the injection date will be excluded
✕. 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
✕. Patient-eyes that do not meet the continuous enrollment requirement will be excluded
✕. Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same 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 7 years

Incidence of RV plus IOI events

Timeframe: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years

Demographics characteristics

Timeframe: 12 months prior to the index date

Clinical characteristics: Number of participants with different retinal disease diagnosis categories

Timeframe: 12 months prior to the index date

Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score

Timeframe: 12 months prior to the index date

Clinical characteristics: Summary of comorbidities reported as number of participants with different categories

Timeframe: 12 months prior to the index date

Clinical characteristics: Number of participants with prior anti-VEGF treatment

Timeframe: 12 months prior to the index date

Trial details

NCT IDNCT07105228

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-30

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.

Exclusion criteria

✕. Aflibercept injections with unspecified laterality will be excluded
✕. Aflibercept injections from individuals aged \<18 years or those with unknown age on the injection date will be excluded
✕. 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
✕. Patient-eyes that do not meet the continuous enrollment requirement will be excluded
✕. Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same 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 7 years

Incidence of RV plus IOI events

Timeframe: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years

Demographics characteristics

Timeframe: 12 months prior to the index date

Clinical characteristics: Number of participants with different retinal disease diagnosis categories

Timeframe: 12 months prior to the index date

Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score

Timeframe: 12 months prior to the index date

Clinical characteristics: Summary of comorbidities reported as number of participants with different categories

Timeframe: 12 months prior to the index date

Clinical characteristics: Number of participants with prior anti-VEGF treatment

Timeframe: 12 months prior to the index date