Calendario›REGN›aflibercept 8 mg PFS

aflibercept 8 mg PFS

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

Ensayo de REGENERON PHARMACEUTICALS, INC. en Diabetic Macular Edema (DME) · Neovascular Age-Related Macular Degeneration (nAMD) (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

35

previstos

Centros

2

Fin del objetivo primario

may 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2024.

Qué mide

Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS (del registro, en inglés) (en el dia 1)

Cómo lo describe el promotor

En el documentoEn inglés, del registroRegeneron 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.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05989126), actualizada en may 2026.