Nonexudative Age Related Macular Degeneration
Conditions
Keywords
AMD, Dry AMD, Nonexudative AMD, MC-1101
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 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.
Interventions
DRUGMC-1101
1% Ophthalmic Solution TID
DRUGMC-1101 Vehicle
Ophthalmic solution, TID
Sponsors
MacuCLEAR, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Function | 12 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia) | 24 months | 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 |
Countries
United States
Outcome results
None listed