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Completed

NCT Number: NCT05989126

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

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.

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Key information

Conditions

Diabetic Macular Edema (DME) Neovascular Age-related Macular Degeneration (nAMD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retina Consultants of Texas, Bellaire, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • 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
  • Treatment with any IVT injection in the study eye within the 25 days prior to day 1
  • Intraocular pressure (IOP) >25 mm Hg in the study eye at screening
  • Any intraocular surgery in the study eye at any time during the past 3 months
  • 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

Treatment and study plan

aflibercept 8 mg PFS

Drug

Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection

Other names: EYLEA ® HD, BAY86-5321

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants With at Least One Ocular Treatment-emergent Adverse Event (TEAE) in the Study Eye

    Time frame: Through Day 29

  2. Number of Participants With at Least One Ocular Serious TEAE in the Study Eye

    Time frame: Through Day 29

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
May 28, 2026

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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