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Lack of efficacy
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The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months |
|
| 30 mg Anecortave Acetate | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months |
|
| Anecortave Acetate Vehicle | Sham Comparator | Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate Sterile Suspension, 30 mg/mL | Drug | Posterior juxtascleral administration of suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sight-threatening CNV in study eye | Month 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to development of sight-threatening CNV | Up to 48 months | |
| Proportion of patients with stable vision | Up to 48 months |
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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 |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Term |
|---|---|
| C418047 | anecortave acetate |
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| Anecortave Acetate Sterile Suspension, 60 mg/ML | Drug | Posterior juxtascleral administration of suspension |
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| Anecortave Acetate Vehicle | Other | Sham posterior juxtascleral administration of suspension |
|