新生血管性加齢黄斑変性症患者におけるファリシマブの長期安全性および忍容性を評価する研究

基本情報

NCT ID

NCT04777201

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

1,036

治験依頼者名

Hoffmann-La Roche

概要

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

対象疾患

介入

依頼者（Sponsor）

実施施設 (39)