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Completed

NCT Number: NCT03767738

Study 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.

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Key information

Conditions

Chorioretinal Vascular Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regeneron Study Site, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal Aflibercept Injection (IAI)

Drug

IAI prepared and administered with a pre-filled syringe (PFS)

Other names: Aflibercept, EYLEA®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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