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 range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.