search
Back to results

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

Primary Purpose

Nonexudative Age Related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MC-1101
MC-1101 Vehicle
Sponsored by
MacuCLEAR, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonexudative Age Related Macular Degeneration focused on measuring AMD, Dry AMD, Nonexudative AMD, MC-1101

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MC-1101 1% Ophthalmic Solution

Vehicle control

Arm Description

Outcomes

Primary Outcome Measures

Visual Function
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)
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

Full Information

First Posted
May 15, 2012
Last Updated
April 24, 2014
Sponsor
MacuCLEAR, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01601483
Brief Title
Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Unmasked without Sponsor's prior knowledge or authorization by the PI.
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacuCLEAR, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonexudative Age Related Macular Degeneration
Keywords
AMD, Dry AMD, Nonexudative AMD, MC-1101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MC-1101 1% Ophthalmic Solution
Arm Type
Experimental
Arm Title
Vehicle control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MC-1101
Intervention Description
1% Ophthalmic Solution TID
Intervention Type
Drug
Intervention Name(s)
MC-1101 Vehicle
Intervention Description
Ophthalmic solution, TID
Primary Outcome Measure Information:
Title
Visual Function
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia)
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant M Comer, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs