Phase II/III Study of the Efficacy and Safety of MacuCLEAR MC-1101 in Treating DryAge-Related Macular Degeneration
NCT ID: NCT02127463
Last Updated: 2014-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2014-04-30
2016-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MC-1101 active
Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime
MC-1101
Topically, two times a day, morning and bedtime
MC-1101 Vehicle Control
Topical Drug:
Ophthalmic Solution Topically, two times per day; morning and bedtime
MC-1101 Vehicle
Topically, two times a day; morning and bedtime
Interventions
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MC-1101
Topically, two times a day, morning and bedtime
MC-1101 Vehicle
Topically, two times a day; morning and bedtime
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
85 Years
ALL
No
Sponsors
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MacuCLEAR, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mitchell J Goff, MD
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Retina Consultants
Locations
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Rocky Mountain Retina Consultants
Murray, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Kari Rasmussen, BS
Role: primary
Katie Roach, RN
Role: backup
Other Identifiers
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MC-1101-003
Identifier Type: -
Identifier Source: org_study_id