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

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