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

NCT05989126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Macular Edema (DME)
  • Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

DRUG

aflibercept 8 mg PFS

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989126 on ClinicalTrials.gov