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Management decision
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The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.
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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 at 6 month intervals for 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL | Drug | One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients who maintained stable vision | Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores) | Month 24 |
| Mean change in best-corrected visual acuity at Month 24 from baseline | Baseline, Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Wiernas, PhD | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK | Central Contact 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 |
| C108423 | AL 3789 |
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