Trials / Terminated
TerminatedNCT02222207
Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration
A Combined Phase IIa / IIb Study of the Efficacy, Safety, and Tolerability of Repeated Topical Doses of Regorafenib Eye Drops, in Treatment-naïve Subjects With Neovascular Age Related Macular Degeneration
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regorafenib, ophthalmic oily suspension (BAY73-4506) | Subjects receive Regorafenib as eye drops |
| PROCEDURE | Sham IVT | Sham injections |
| DRUG | Ranibizumab | Subjects receive Ranibizumab as intravitreal injection |
| DRUG | Placebo | Placebo eye drops |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-05-01
- Completion
- 2015-06-01
- First posted
- 2014-08-21
- Last updated
- 2016-09-08
- Results posted
- 2016-09-08
Locations
149 sites across 18 countries: United States, Australia, Austria, Canada, Chile, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Slovakia, South Korea, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02222207. Inclusion in this directory is not an endorsement.