Nonexudative Age Related Macular Degeneration Clinical Trial
Official title:
Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
| Verified date | April 2014 |
| Source | MacuCLEAR, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 22 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| 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 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; Exclusion Criteria: - 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); - Liver disease (e.g. cirrhosis, hepatitis); - History of GI surgery (e.g. bariatric surgery); - Unwilling or unable to take an AREDS formula vitamin (without beta-carotene/vitamin A); - Current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), or deferoxamine; - Tobacco smoking (currently or within past 5 years); - 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 of enrollment; - Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study; - Known to have AIDS/HIV |
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 | University of Michigan | Ann Arbor | Michigan |
| 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. | 12 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-1101 compared to vehicle control at each study visit following treatment for 2 years | 24 months | Yes |