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

Inclusion Criteria:

- Able to read (or, if unable to read due to visual impairment, be read to verbatim by
the person administering the informed consent or a family member) and able to
understand the informed consent form (ICF)

- Men and women ≥ 50 years of age

- Active primary subfoveal CNV (Choroidal neovascularization) lesions secondary to AMD
(Age-related macular degeneration), including juxtafoveal lesions that affect the
fovea as evidenced by FA (Fluorescein angiography) in the study eye and reviewed by
the central reading center

- The area of CNV must occupy at least 50% of total lesion in the study eye, as
determined by FA review at the central reading center

- Evidence of intraretinal and/or subretinal fluid on OCT (Optical coherence
tomography)

- Early Treatment Diabetic Retinopathy Study BCVA of 73 to 25 letters (20/40 to 20/320
Snellen equivalent) in the study eye

- Willing, committed, and able to return for all clinic visits and complete all study
related procedures

- Women of childbearing potential and men must agree to use adequate contraception when
sexually active. This applies since signing of the ICF until one month after the EOS
visit. The definition of adequate contraception will be based on the judgment of the
investigator.

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.