Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration
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|ClinicalTrials.gov Identifier: NCT01601483|
Recruitment Status : Terminated (Unmasked without Sponsor's prior knowledge or authorization by the PI.)
First Posted : May 18, 2012
Last Update Posted : April 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonexudative Age Related Macular Degeneration||Drug: MC-1101 Drug: MC-1101 Vehicle||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|Experimental: MC-1101 1% Ophthalmic Solution||
1% Ophthalmic Solution TID
|Placebo Comparator: Vehicle control||
Drug: MC-1101 Vehicle
Ophthalmic solution, TID
- Visual Function [ Time Frame: 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.
- Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601483
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Grant M Comer, MD||University of Michigan|