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The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anecortave Acetate 3 mg Depot | Experimental | Single injection, anterior juxtascleral depot (AJD) |
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| Anecortave Acetate 15 mg Depot | Experimental | Single injection, anterior juxtascleral depot (AJD) |
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| Anecortave Acetate 30 mg Depot | Experimental | Single injection, anterior juxtascleral depot (AJD) |
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| Anecortave Acetate Vehicle | Other | Single injection, anterior juxtascleral depot (AJD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate Sterile Suspension, 6 mg/mL | Drug | Single injection, anterior juxtascleral depot (AJD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in intraocular pressure at 9 am from baseline | Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure | At time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Landry | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C418047 | anecortave acetate |
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| Anecortave Acetate Sterile Suspension, 30 mg/mL | Drug | Single injection, anterior juxtascleral depot (AJD) |
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| Anecortave Acetate Sterile Suspension, 60 mg/mL | Drug | Single injection, anterior juxtascleral depot (AJD) |
|
| Anecortave Acetate Vehicle | Other | Single injection, anterior juxtascleral depot (AJD) |
|