phase ii/iii study of the efficacy and safety of macuclear mc-1101 in treating dryage-related macular degeneration

Conditions: Non-Exudative Age Related Macular Degeneration

Summary: 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.

Eligibility criteria:
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

Keywords: amd dry amd non-exudative amd mc-1101