Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT06769412
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2024-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: