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The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrase | Experimental | A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrase | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitreous detachment | The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28 | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Williams, PhD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edgar L. Thomas, MD | Beverly Hills | California | 90211 | United States | ||
| Ronni Lieberman, MD |
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| ID | Term |
|---|---|
| D020255 | Vitreous Detachment |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002810 | Chondroitinases and Chondroitin Lyases |
| ID | Term |
|---|---|
| D013429 | Sulfatases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 |
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| New York |
| New York |
| 10021 |
| United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| The Virginia Retina Center | Leesburg | Virginia | 20176 | United States |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |