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レゴラフェニブ点眼薬:新生血管性加齢黄斑変性における有効性および安全性の検討

基本情報

NCT ID
NCT02222207
ステータス
中止
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
52
治験依頼者名
Bayer

概要

Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: * how often the regorafenib eye drops need to be given per day * whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.

対象疾患

Macular Degeneration

介入

Regorafenib, ophthalmic oily suspension (BAY73-4506)(DRUG)
Sham IVT(PROCEDURE)
Ranibizumab(DRUG)
Placebo(DRUG)

依頼者(Sponsor)