NCT05989126

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	aflibercept 8 mg PFS	Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-08-14
• Last updated: 2025-05-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study