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

NCT ID: NCT01601483

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

Brief 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.

Conditions

Nonexudative Age Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MC-1101 1% Ophthalmic Solution

Group Type: EXPERIMENTAL

MC-1101

Intervention Type: DRUG

1% Ophthalmic Solution TID

Vehicle control

Group Type: PLACEBO_COMPARATOR

MC-1101 Vehicle

Intervention Type: DRUG

Ophthalmic solution, TID

Interventions

MC-1101

1% Ophthalmic Solution TID

Intervention Type: DRUG

MC-1101 Vehicle

Ophthalmic solution, TID

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MacuCLEAR, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grant M Comer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

MacuCLEAR MC-1101-001

Identifier Type: -

Identifier Source: org_study_id