Clinical trial 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)
Official title: Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 550000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Detailed description: 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

Eligibility criteria: Key Inclusion 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)

Key Exclusion Criteria:

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

NOTE: Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence of RV events
timeFrame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
measure: 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
measure: 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
measure: Incidence of unconfirmed RV events
timeFrame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: