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| Name | Class |
|---|---|
| Duke University | OTHER |
| Trial Runners, LLC | OTHER |
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A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0mg Luminate® | Experimental | 1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) |
|
| 2.0mg Luminate® | Experimental | 2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) |
|
| 3.0mg Luminate® | Experimental | 3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) |
|
| Balanced Salt Solution 0.10cc | Placebo Comparator | Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.0mg Luminate® | Drug |
| ||
| 2.0mg Luminate® |
| Measure | Description | Time Frame |
|---|---|---|
| Observation of pharmacologic induction of PVD. | The primary endpoint of this study is observation of pharmacologic induction of at least a stage 3 PVD, with PVD defined as a complete PVD to the equator except for vitreopapillary adhesion as seen on B-scan Ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoints of this study is the observation of a complete stage 4 PVD to the equator including vitreopapillary release as seen by B-scan ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center. | The secondary endpoints of this study is the observation of a complete stage 4 PVD to the equator including vitreopapillary release as seen by B-scan ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicken Karageozian, MD | Medical monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States | ||
| UCI Medical Center |
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|
| 3.0mg Luminate® | Drug |
|
| Balanced Salt Solution for intravitreal injection in 0.10cc | Other |
|
| 90 days |
| Orange |
| California |
| 92868 |
| United States |
| New England Retina Associates | New London | Connecticut | 06320 | United States |
| Center for Retina and Macular Disease | Lakeland | Florida | 33805 | United States |
| Illinois Retina Center | Springfield | Illinois | 62704 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Retina Research Institute Of Texas | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| The Retina Group of Washington | Fairfax | Virginia | 22031 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| C000712274 | risuteganib |
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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