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Management Decision
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The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anecortave Acetate, 15 mg | Experimental | One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months. |
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| Anecortave Acetate, 30 mg | Experimental | One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months. |
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| Anecortave Acetate Vehicle | Sham Comparator | One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate Sterile Suspension, 30 mg/mL | Drug | One 0.5 mL injection into the PJD at 6-month intervals for 42 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye | Month 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to development of sight-threatening CNV | Timepoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Wiernas, PhD | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| India | Bangalore | 76134 | India |
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| ID | Term |
|---|---|
| C418047 | anecortave acetate |
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| Anecortave Acetate Sterile Suspension, 60 mg/mL | Drug | One 0.5 mL injection into the PJD at 6-month intervals for 42 months |
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| Anecortave Acetate Vehicle | Other | One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye. |
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