Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
Stopped early · Phase 2/Phase 3
Conditions studied: Nonexudative Age Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT01601483
- Run by
- MacuCLEAR, Inc.
- People needed
- 22
- Starts
- 2012-10-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2014-04-28
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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