Retinal Vasculitis
Conditions
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)
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
Interventions
DRUGaflibercept 2 mg
No study-specific investigations for this descriptive observational study
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed