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Unmasked without Sponsor's prior knowledge or authorization by the PI.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC-1101 1% Ophthalmic Solution | Experimental |
| |
| Vehicle control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC-1101 | Drug | 1% Ophthalmic Solution TID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Function | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (incidence and severity of adverse events, ocular irritability, ocular hyperemia) | 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 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant M Comer, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
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| MC-1101 Vehicle |
| Drug |
Ophthalmic solution, TID |
|