Calendario›REGN›PANORAMA

PANORAMA

Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

Ensayo de REGENERON PHARMACEUTICALS, INC. en Nonproliferative Diabetic Retinopathy (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

402

previstos

Centros

89

Fin del objetivo primario

ago 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2016.

Qué mide

Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups (del registro, en inglés) (en la semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR). The secondary objectives of the study are: * To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR * To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME * To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02718326), actualizada en jul 2020.