Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Phase 3
Completed
NCT05989126
| Condition | Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration |
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| Phase | Phase 3 |
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| Sponsor | Regeneron Pharmaceuticals |
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| Status | Completed |
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| Enrollment | 35 participants |
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| Interventions | aflibercept 8 mg PFS |
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| Start date | Apr 15, 2024 |
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| Completion date | May 31, 2024 |
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| Results posted | May 28, 2026 |
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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.
Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS
At Day 1 · injections
| Aflibercept 8 mg PFS | 35 injections |
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Open in BENITIONS
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