Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular … (NCT01601483) | Clinical Trial Compass
TerminatedPhase 2/3
Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
Stopped: Unmasked without Sponsor's prior knowledge or authorization by the PI.
United States22 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range50 Years – 85 Years
SexALL
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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 co…