Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Chorioretinal Vascular Disease

Treatments

Drug: Intravitreal Aflibercept Injection (IAI)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03767738

VGFTe-OD-1881

Details and patient eligibility

About

The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.

The secondary objective of the study is to assess ocular safety in the study eye.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye

Key Exclusion Criteria:

Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
Any intraocular surgery in the study eye at any time during the past 3 months
Current systemic infectious disease or a therapy for active infectious disease
Pregnant or breastfeeding women

Note: Other inclusion/ exclusion apply