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

Sponsor

MacuCLEAR, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01601483

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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

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 :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 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

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

Visual Function [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

Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia) [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

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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