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

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ClinicalTrials.gov Identifier: NCT01601483
Recruitment Status : Terminated (Unmasked without Sponsor's prior knowledge or authorization by the PI.)
First Posted : May 18, 2012
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
MacuCLEAR, Inc.

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 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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601483


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

Responsible Party: MacuCLEAR, Inc.
ClinicalTrials.gov Identifier: NCT01601483     History of Changes
Other Study ID Numbers: MacuCLEAR MC-1101-001
First Posted: May 18, 2012    Key Record Dates
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
Ophthalmic Solutions
Pharmaceutical Solutions