Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
第3相
完了
NCT05989126
| 対象疾患 | Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration |
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| 相 | 第3相 |
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| スポンサー | Regeneron Pharmaceuticals |
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| ステータス | 完了 |
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| 参加者数 | 35 名 |
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| 介入（薬剤） | aflibercept 8 mg PFS |
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| 開始日 | 2024年4月15日 |
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| 完了日 | 2024年5月31日 |
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| 結果公開日 | 2026年5月28日 |
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概要
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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