Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)

May 1, 2026 updated by: Regeneron Pharmaceuticals

A Study in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration to Evaluate a High Dose Aflibercept (8 mg) Prefilled Syringe

Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial.

This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).

The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

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
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • The Woodlands, Texas, United States, 77385
        • Retina Consultants of Texas

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye
  2. Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept

Key Exclusion Criteria:

  1. Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye
  2. Treatment with any IVT injection in the study eye within the 25 days prior to day 1
  3. Intraocular pressure (IOP) >25 mm Hg in the study eye at screening
  4. Any intraocular surgery in the study eye at any time during the past 3 months
  5. Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye

NOTE: Other protocol Defined Inclusion/Exclusion Criteria 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 8 mg Dose
Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS.
Drug: aflibercept 8 mg PFS
Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection
Other Names:
  • BAY86-5321
  • EYLEA ® HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the 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
Time Frame
Number of Participants With at Least One Ocular Treatment-emergent Adverse Event (TEAE) in the Study Eye
Time Frame: Through Day 29
Through Day 29
Number of Participants With at Least One Ocular Serious TEAE in the Study Eye
Time Frame: Through Day 29
Through Day 29

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, 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)

April 15, 2024

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFTe-HD-OD-22105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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