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

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MacuCLEAR, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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