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

Exclusion Criteria

• •Concurrent disease in the study eye, other than AMD (e.g., corneal diseases and dystrophies, conjunctival diseases, eye lid abnormalities, or any other diseases of the cornea and macula, or optic nerve abnormality) that could compromise visual acuity, likely require medical or surgical intervention during the study period, would limit the potential to gain or lose vision during study treatment, or could otherwise confound interpretation of the results
• •Total lesion size (including neovascularization, scar, blood) \> 12 disc areas (30.5 mm2) as assessed by FA
• •Only one functional eye, even if that eye is otherwise eligible for the study
• •Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye except dietary supplements or vitamins
• •Prior treatment with any systemic anti-VEGF (Vascular endothelial growth factor) agent
• •Use of systemic or ocular treatment with an investigational drug within 12 weeks prior to start of study treatment
• •Any other condition that would require frequent chronic co-administration of other topical eye medications that would interfere with study drug administration (e.g. contact lens)
• •Symptoms or conditions consistent with contraindications listed in the current local label for ranibizumab
• •Participation in an investigational study within 30 days prior to start of study treatment that involved treatment with any drug (excluding vitamins and minerals) or device
• •Lactating women and women of child-bearing potential with either a positive pregnancy test result or no pregnancy test at screening are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.