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中等度から重度の非増殖性糖尿病網膜症(NPDR)の改善における硝子体内(IVT)アフリベルセプトの有効性および安全性に関する研究

基本情報

NCT ID
NCT02718326
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
402
治験依頼者名
Regeneron Pharmaceuticals

概要

The 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

対象疾患

Nonproliferative Diabetic Retinopathy

介入

Intravitreal aflibercept injection [IAI](DRUG)
Sham(DRUG)

依頼者(Sponsor)

Regeneron(INDUSTRY)