Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ranibizumab | Monoclonal antibody | — | Intravitreal |
| Subject | Regorafenib | Small molecule | — | Topical |