Recruiting
Phase 2
Phase 3

MacuCLEAR MC-1101

Sponsor:

MacuCLEAR, Inc.

Code:

NCT02127463

Conditions

Non-Exudative Age Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

MC-1101

MC-1101 Vehicle

Study Details

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 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.

Conditions

Non-Exudative Age Related Macular Degeneration

Study ID

NCT02127463

Start date

Apr, 2014

Status verified date

Apr, 2014

Completion date

Apr, 2016

Anticipated

Primary completion date

Apr, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MC-1101 active

Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime

placebo comparator: MC-1101 Vehicle Control

Topical Drug:

Ophthalmic Solution Topically, two times per day; morning and bedtime

Interventions

MC-1101

Topically, two times a day, morning and bedtime

MC-1101 Vehicle

Topically, two times a day; morning and bedtime

Primary outcome measure

  • Visual Function [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Philip G Ralston, MBA

2145775999pralston@macuclear.com

Mitchell J Goff, MD

8012644444mmmgoff@yahoo.com

Locations

Rocky Mountain Retina Consultants

Recruiting

Murray, Utah, United States, 84107

Contacts

Kari Rasmussen, BS

801-264-4444kmrasmussen@yahoo.com

Katie Roach, RN

8012644444katie.roach@rockymountainretina.com

Principal Investigator:

Mitchell J Goff, MD

More Information

Sponsor

MacuCLEAR, Inc.

Last update posted

Apr 30, 2014

Last verified

Apr, 2014

Keywords

  • AMD
  • Dry AMD
  • Non-Exudative AMD
  • MC-1101

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MacuCLEAR, Inc. on 2014-04-30.