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The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg Anecortave Acetate, 3 month intervals | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months). |
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| 15 mg Anecortave Acetate, 6 month intervals | Experimental | Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). |
|
| 30 mg Anecortave Acetate, 6 month intervals | Experimental | Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). |
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| Anecortave Acetate Vehicle | Sham Comparator | One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate Sterile Suspension, 30 mg/mL | Drug | One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in lesion growth at Month 12 from baseline | Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Investigators | Alcon Research | Principal Investigator |
| Patricia Zilliox, Ph.D. | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Study Sites | Fort Worth | Texas | 76134 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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 posterior juxtascleral depot injection at 6 month intervals |
|
| Anecortave Acetate Vehicle | Other | One 0.5 mL sham injection at 6 month intervals |
|