Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

August 18, 2021 updated by: Regeneron Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Regeneron Study Site
      • The Woodlands, Texas, United States, 77384
        • Regeneron Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intravitreal Aflibercept Injection (IAI)
Cohort 1 - Initial patients Cohort 2 - Additional patients
Drug: Intravitreal Aflibercept Injection (IAI)
IAI prepared and administered with a pre-filled syringe (PFS)
Other Names:
  • EYLEA®
  • Aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
Time Frame: At Day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Time Frame: Baseline 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
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
Time Frame: Baseline 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2018

Primary Completion (ACTUAL)

August 19, 2020

Study Completion (ACTUAL)

August 19, 2020

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (ACTUAL)

December 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFTe-OD-1881

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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