Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Completed · Phase 3
Conditions studied: Diabetic Macular Edema (DME), Neovascular Age-Related Macular Degeneration (nAMD)
In brief
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.
Key facts
- Study ID
- NCT05989126
- Run by
- Regeneron Pharmaceuticals
- People needed
- 35
- Starts
- 2024-04-15
- Expected to finish
- 2024-05-31
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Retina Consultants of Texas — Bellaire, Texas, United States
- Retina Consultants of Texas — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
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