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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 non-exudative 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 Baseline, 1, 3, 6, 12,18 and 24 months.
MC-1101is a topically administered drug which in previous clinical studies has been proven to get to the back of the eye. MC-1101is a 505 (b) 2 compound and has FDA Fast Track Status. It is a strong, vasoactive drug which is intended to increase choroidal blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC-1101 active | Experimental | Topical Drug 1% Ophthalmic Solution Topically, two times per day; morning and bedtime |
|
| MC-1101 Vehicle Control | Placebo Comparator | Topical Drug: Ophthalmic Solution Topically, two times per day; morning and bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC-1101 | Drug | Topically, two times a day, morning and bedtime |
|
| 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 measured by dark adaptation methodology. | Up to 24 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-1101compared to a vehicle control at each study visit following treatment for 2 years. | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip G Ralston, MBA | Contact | 2145775999 | pralston@macuclear.com | |
| Mitchell J Goff, MD | Contact | 8012644444 | mmmgoff@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell J Goff, MD | Rocky Mountain Retina Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Retina Consultants | Recruiting | Murray | Utah | 84107 | United States |
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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| MC-1101 Vehicle | Drug | Topically, two times a day; morning and bedtime |
|
|
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |