Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration

Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 1.0% BID in the Treatment of Non-exudative Age-Related Macular Degeneration

This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate non-exudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients.

An analysis of the primary and secondary endpoints will be conducted when all subjects have completed Baseline, 1, 3, 6, 12,18 and 24 months.

MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.

Inclusion Criteria:

• Males and females age ≥ 50 years and ≤ 85 years
• Females only: At least 1year since last menstrual period or surgically sterilized
• 20/80 or better ETDRS best corrected visual acuity
• Early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories
• Willing and able to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing at each visit
• Able to reliably to complete biophysical testing
• Willing to take an AREDS2 based formula vitamin as indicated

Exclusion Criteria:

• Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories)
• Past or current retinal or choroidal vasculopathy in study eye (e.g. serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy)
• Uncontrolled hypertension (≥ 160 systolic or ≥95 diastolic)
• Glaucoma
• 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 small bowel surgery
• Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), deferoxamine, amiodorone, isoretinoin, or gold
• 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 prior to screening visit of this study
• Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study
• Known to have AIDS/HIV
• Current use of hydralazine
• Any other findings deemed unacceptable by the Principal Investigator or Sponsor