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

• Status: Terminated
• Trial end date: 2013-03-01
• 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 nonexudative 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 12, 18 and 24 months.

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

Details

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

Criteria

Inclusion Criteria:

• Males and females age ≥ 50 years and ≤ 85 years;

• Females must be at least 1 year postmenopausal (after last menstrual period) or sterilized;

• Better than 20/80 ETDRS best corrected visual acuity;

• Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale);

• Willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit;

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