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The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with age-related macular degeneration.
Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | OT-551 0.3% ophthalmic solution |
|
| 2 | Experimental | OT-551 0.45% ophthalmic solution |
|
| 3 | Placebo Comparator | vehicle placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OT-551 | Drug | OT-551 0.3% ophthalmic solution, 2 drops 4 times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the area of GA | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa | Arizona | United States | ||||
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| Label | URL |
|---|---|
| Othera Pharmaceuticals, Inc. website | View source |
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| OT-551 |
| Drug |
OT-551 0.45% ophthalmic solution, 2 drops 4 times daily |
|
| vehicle placebo | Drug | OT-551 0% ophthalmic solution, 2 drops 4 times daily |
|
| Tucson |
| Arizona |
| United States |
| Beverly Hills | California | United States |
| Oxnard | California | United States |
| Sacramento | California | United States |
| Denver | Colorado | United States |
| Boynton Beach | Florida | United States |
| Miami | Florida | United States |
| Indianapolis | Indiana | United States |
| Novi | Michigan | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Cleveland | Ohio | United States |
| Lakewood | Ohio | United States |
| Portland | Oregon | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C550190 | OT-551 |
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