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

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