Non-Exudative Age Related Macular Degeneration Clinical Trial
— McCP2/3Official title:
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Rocky Mountain Retina Consultants | Murray | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| MacuCLEAR, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 measured by dark adaptation methodology. | Up to 24 months | No |
| Secondary | 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-1101compared to a vehicle control at each study visit following treatment for 2 years. | Up to 24 months | Yes |