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This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THR-687 dose level 1 | Experimental | Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1 |
|
| THR-687 dose level 2 | Experimental | Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2 |
|
| THR-687 dose level 3 | Experimental | Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THR-687 dose level 1 | Drug | single intravitreal injection of THR-687 dose level 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities up to the Day 14 visit | From Day 0 up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study | From Day 0 up to Day 84 | |
| Occurrence of laboratory abnormalities up to the end of the study | At Screening, Day 1, Day 7, Day 28 and Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Department | ThromboGenics Inc. A subsidiary of Oxurion NV. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Arizona | Phoenix | Arizona | 85053 | United States | ||
| Center for Retina and Macular Disease |
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| THR-687 dose level 2 |
| Drug |
single intravitreal injection of THR-687 dose level 2 |
|
| THR-687 dose level 3 | Drug | single intravitreal injection of THR-687 dose level 3 |
|
| Winter Haven |
| Florida |
| 33880 |
| United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Palmetto Retinal Center | West Columbia | South Carolina | 29169 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606-1224 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
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