Conditions: Macular Degeneration
Keywords: neovascular Age-related Macular Degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Part A: Patients will receive Regorafenib eye drops arm 2: Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 3: Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 4: Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 5: Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 6: Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 7: Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 8: Ranibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens

Interventions: intervention 1: Regorafenib, ophthalmic oily suspension (BAY73-4506) intervention 2: Sham IVT intervention 3: Ranibizumab intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects receive Regorafenib as eye drops intervention 2: Sham injections intervention 3: Subjects receive Ranibizumab as intravitreal injection intervention 4: Placebo eye drops

Protocol document: