Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Chorioretinal Vascular Disease Clinical Trial

Official title:

A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767738
• Other study ID #: VGFTe-OD-1881
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2018
• Est. completion date: August 19, 2020

Study information

• Verified date: August 2021
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chorioretinal Vascular Disease
• Vascular Diseases

Intervention

Drug:
• Intravitreal Aflibercept Injection (IAI)
IAI prepared and administered with a pre-filled syringe (PFS)

Locations

Country	Name	City	State
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)	Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.	At Day 1
Secondary	Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29	A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.	Baseline through Day 29
Secondary	Incidence of Ocular Serious TEAEs of Study Eye Through Day 29	A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.	Baseline through Day 29