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

• ClinicalTrials.gov Identifier: NCT01601483
• Recruitment Status: Terminated
• First Posted: May 18, 2012
• Last Update Posted: April 28, 2014
• Sponsor: MacuCLEAR, Inc.
• Information provided by (Responsible Party): MacuCLEAR, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nonexudative Age Related Macular Degeneration	Drug: MC-1101; Drug: MC-1101 Vehicle	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
• Study Start Date: October 2012
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: MC-1101 1% Ophthalmic Solution	Drug: MC-1101; 1% Ophthalmic Solution TID
Placebo Comparator: Vehicle control	Drug: MC-1101 Vehicle; Ophthalmic solution, TID

Outcome Measures

Primary Outcome Measures :

1. Visual Function [ Time Frame: 12 months ]
   Primary efficacy assessment will be a comparison between groups of the change in visual function at 12 months with additional analyses at 18 and 24 months.

Secondary Outcome Measures :

1. Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia) [ Time Frame: 24 months ]
   Evaluate the safety and tolerability (incidence and severity of adverse events, ocular irritability,and ocular hyperemia) of MC-1101 compared to vehicle control at each study visit following treatment for 2 years

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48105

Sponsors and Collaborators

MacuCLEAR, Inc.

Investigators

• Principal Investigator: Grant M Comer, MD; University of Michigan

More Information

• Responsible Party: MacuCLEAR, Inc.
• ClinicalTrials.gov Identifier: NCT01601483
• Other Study ID Numbers: MacuCLEAR MC-1101-001
• First Posted: May 18, 2012
• Last Update Posted: April 28, 2014
• Last Verified: April 2014

Keywords provided by MacuCLEAR, Inc.:

AMD; Dry AMD; Nonexudative AMD; MC-1101

Additional relevant MeSH terms:

Macular Degeneration; Geographic Atrophy; Retinal Degeneration; Retinal Diseases; Eye Diseases