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Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767738
Recruitment Status : Completed
First Posted : December 7, 2018
Results First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chorioretinal Vascular Disease Drug: Intravitreal Aflibercept Injection (IAI) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : August 19, 2020
Actual Study Completion Date : August 19, 2020

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Arms and Interventions
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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:
  • Aflibercept
  • EYLEA®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767738


Locations
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United States, Texas
Regeneron Study Site
Houston, Texas, United States, 77030
Regeneron Study Site
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] May 1, 2020
Statistical Analysis Plan  [PDF] February 6, 2019

More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03767738    
Other Study ID Numbers: VGFTe-OD-1881
First Posted: December 7, 2018    Key Record Dates
Results First Posted: September 16, 2021
Last Update Posted: September 16, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents