Status:
COMPLETED
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Chorioretinal Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03767738
Start Date
December 19 2018
End Date
August 19 2020
Last Update
September 16 2021
Active Locations (2)
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1
Regeneron Study Site
Houston, Texas, United States, 77030
2
Regeneron Study Site
The Woodlands, Texas, United States, 77384