Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

• Status: Completed
• Trial end date: 2020-08-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Aflibercept

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