Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration (McCP2/3)

April 29, 2014 updated by: MacuCLEAR, Inc.

Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 1.0% BID in the Treatment of Non-exudative Age-Related Macular Degeneration

This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate non-exudative 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 Baseline, 1, 3, 6, 12,18 and 24 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females age ≥ 50 years and ≤ 85 years
  • Females only: At least 1year since last menstrual period or surgically sterilized
  • 20/80 or better ETDRS best corrected visual acuity
  • Early to intermediate nonexudative AMD (AMD category 3 through 3b on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories
  • Willing and able to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing at each visit
  • Able to reliably to complete biophysical testing
  • Willing to take an AREDS2 based formula vitamin as indicated

Exclusion Criteria:

  • Past or current exudative AMD or central geographic atrophy in study eye; (AMD Category 4 on Age-Related Eye Disease Study (AREDS) Report No. 8 AMD Categories)
  • Past or current retinal or choroidal vasculopathy in study eye (e.g. serous or hemorrhagic pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous chorioretinopathy, retinal vein occlusion, sickle cell retinopathy)
  • Uncontrolled hypertension (≥ 160 systolic or ≥95 diastolic)
  • Glaucoma
  • 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 small bowel surgery
  • Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), deferoxamine, amiodorone, isoretinoin, or gold
  • 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 prior to screening visit of this study
  • Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study
  • Known to have AIDS/HIV
  • Current use of hydralazine
  • Any other findings deemed unacceptable by the Principal Investigator or Sponsor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MC-1101 active
Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime
Drug: MC-1101
Topically, two times a day, morning and bedtime
Other Names:
  • 1% Ophthalmic Solution
Placebo Comparator: MC-1101 Vehicle Control

Topical Drug:

Ophthalmic Solution Topically, two times per day; morning and bedtime
Drug: MC-1101 Vehicle
Topically, two times a day; morning and bedtime
Other Names:
  • Topical Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Function
Time Frame: Up to 24 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 measured by dark adaptation methodology.
Up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MacuCLEAR, Inc.

Investigators

  • Principal Investigator: Mitchell J Goff, MD, Rocky Mountain Retina Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-1101-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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