Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Experimental | 5 up to 6 patients per arm. Emulsion at 0.8% of drug product. |
|
| cohort 2 | Experimental | 5 up to 6 patients per arm. Emulsion at 0.8% of drug product. |
|
| cohort 3 | Experimental | 5 up to 6 patients per arm. Emulsion at 3.2% of drug product. |
|
| cohort 4 | Experimental | 5 up to 6 patients per arm. Oily solution at 3.4% of drug product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOVA63035 "Corticosteroid" | Drug | Single injection in the study eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety | Over one year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Eye Institute | Indianapolis | Indiana | 46280 | United States |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |