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The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 mg Anecortave Acetate, low volume high dose | Experimental | Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. |
|
| 3 mg Anecortave Acetate, high volume low dose | Experimental | Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. |
|
| 48 mg Anecortave Acetate, low volume high dose | Experimental | Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. |
|
| 48 mg Anecortave Acetate, high volume low dose | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. |
|
| Anecortave Acetate Vehicle, low volume | Placebo Comparator | Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate Sterile Suspension, 6 mg/mL | Drug | Administered as an injection into an anterior juxtascleral depot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients who remain rescue-medication free | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
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|
| Anecortave Acetate Vehicle, high volume | Placebo Comparator | Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months. |
|
| Anecortave Acetate Sterile Suspension, 3.75 mg/mL | Drug | Administered as an injection into an anterior juxtascleral depot |
|
| Anecortave Acetate Sterile Suspension, 96 mg/mL | Drug | Administered as an injection into an anterior juxtascleral depot |
|
| Anecortave Acetate Sterile Suspension, 60 mg/ML | Drug | Administered as an injection into an anterior juxtascleral depot |
|
| Anecortave Acetate Vehicle | Other | Administered as an injection into an anterior juxtascleral depot |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C418047 | anecortave acetate |
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