Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

Inclusion Criteria:

- Males and females age ≥ 50 years and ≤ 85 years;

- Females must be at least 1 year postmenopausal (after last menstrual period) or
sterilized;

- Better than 20/80 ETDRS best corrected visual acuity;

- Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease
Study (AREDS) Report No. 17 grading scale);

- Willing to sign informed consent, comply with study protocol requirements, and
undergo up to 2.5 hours of testing at each visit;

Exclusion Criteria:

- Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence)
in study eye;

- Past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment
epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy,
retinal vein occlusion, sickle cell retinopathy);

- Uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic);

- Diabetes mellitus;

- Glaucoma;

- Lens opacity ≥ grade 3 ARLNS on standard photographs;

- Unable to complete biophysical testing;

- Unable to give informed consent;

- Dilated pupil diameter less than 6 millimeters;

- Subjects with a history of a hypersensitivity reaction to the study drug or to any
agent used in the components of the study assessment;

- Use of topical ocular medications (other than artificial tear products);

- Anticipated extra- or intraocular intervention during the study period;

- High myopia (refractive error spherical equivalent ≥ -6 diopters);

- Optic neuropathy;

- Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple
sclerosis, Alzheimer's disease);

- Liver disease (e.g. cirrhosis, hepatitis);

- History of GI surgery (e.g. bariatric surgery);

- Unwilling or unable to take an AREDS formula vitamin (without beta-carotene/vitamin
A);

- Current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine,
quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), or deferoxamine;

- Tobacco smoking (currently or within past 5 years);

- Contact lens wearers (not prepared to discontinue lens use);

- Ophthalmic surgery of any kind within 3 months prior to screening visit;

- Participation in any interventional clinical study requiring IRB approval within 3
months of enrollment;

- Currently being treated for cancer or any disease likely to adversely affect
participation in a 2 year study;

- Known to have AIDS/HIV