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

NCT01601483 | Terminated Phase 2

• 1 other identifier: MacuCLEAR MC-1101-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

AMD; Dry AMD; Nonexudative AMD; MC-1101

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

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

  24 months

Study Arms (2)

MC-1101 1% Ophthalmic Solution

EXPERIMENTAL

Drug: MC-1101

Vehicle control

PLACEBO COMPARATOR

Drug: MC-1101 Vehicle

Interventions

MC-1101 DRUG

1% Ophthalmic Solution TID

MC-1101 1% Ophthalmic Solution

MC-1101 Vehicle DRUG

Ophthalmic solution, TID

Vehicle control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• MacuCLEAR, Inc.: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Study Officials

• Grant M Comer, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 18, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

US (1)