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Management decision
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A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-3789 | Experimental | One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months. |
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| Anecortave Acetate Vehicle | Sham Comparator | One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg | Drug | One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 | ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site. | Month 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Zilliox | Study Manager | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Centers in the United States and Globally | Fort Worth | Texas | 76134 | United States |
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| ID | Term |
|---|---|
| C418047 | anecortave acetate |
| C108423 | AL 3789 |
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| Anecortave Acetate Vehicle | Other | One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye. |
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