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Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.
MC-1101 is a topical version of a previously approved anti-hypertensive drug that is intended to increase choroidal blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug, MC-1101 | Active Comparator | One eye drop of Active comparator, 0.5% MC-1101, 2 times per day, 28 days; followed by one drop of 1% MC-1101, 2 times per day, 28 days. |
|
| Placebo | Placebo Comparator | One eye drop of Placebo comparator to MC-1101. Placebo contains all components of MC-1101 except for the active ingredient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC-1101, Placebo | Drug | One drop 0.5%; MC-1101; One drop 1.0% MC-1101, One drop Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| No significant ocular or systemic adverse events in any of the 20 study subjects | Assess the safety and tolerability of MC-1101 by evaluating the local ocular and systemic safety of MC-1101 0.5 % and 1 % in subjects in a dose escalation manner over 8 weeks of daily ocular exposure. | 56 total days |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic:
General/Systemic:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Sall, MD | Sall Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Eye Center | Artesia | California | 90701 | United States |
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