drugset / Trial / NCT02222207

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

NCT02222207

Phase 2 Terminated 52 enrolled Bayer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2014-10
Primary completion
2015-05
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ranibizumab Monoclonal antibody Intravitreal
Subject Regorafenib Small molecule Topical

Indications