Macular Degeneration Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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