A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)
Part of paid clinical trials in Tarrytown, New York.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT06769412
- Status
- Completed
Conditions
- Retinal Vasculitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- aflibercept 2 mg — DRUGNo study-specific investigations for this descriptive observational study
Study Details
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.
Key Dates
- Start date
- Jul 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Aug 15, 2025
- Completion
- Sep 1, 2025
Study Design
- Enrollment
- 550,000 participants (actual)
Arms
- Arm: Aflibercept IVT CohortPatients ≥ 18 years who initiated aflibercept 2 mg IVT during the study period
Primary Outcome Measure
Incidence of RV events [ Time Frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Regeneron Research Site | Tarrytown | New York | 10591 | - |
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