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Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Primary Purpose

Chorioretinal Vascular Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravitreal Aflibercept Injection (IAI)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorioretinal Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regeneron Study Site
  • Regeneron Study Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal Aflibercept Injection (IAI)

Arm Description

Cohort 1 - Initial patients Cohort 2 - Additional patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 5, 2018
Last Updated
August 18, 2021
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03767738
Brief Title
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Official Title
A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
August 19, 2020 (Actual)
Study Completion Date
August 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 the study is to assess ocular safety in the study eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorioretinal Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Aflibercept Injection (IAI)
Arm Type
Experimental
Arm Description
Cohort 1 - Initial patients Cohort 2 - Additional patients
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection (IAI)
Other Intervention Name(s)
Aflibercept, EYLEA®
Intervention Description
IAI prepared and administered with a pre-filled syringe (PFS)
Primary Outcome Measure Information:
Title
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
Description
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.
Time Frame
At Day 1
Secondary Outcome Measure Information:
Title
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
Description
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.
Time Frame
Baseline through Day 29
Title
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
Description
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.
Time Frame
Baseline through Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Regeneron Study Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

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Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

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