Anecortave Acetate Risk-Reduction Trial (AART)
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|ClinicalTrials.gov Identifier: NCT00307398|
Recruitment Status : Terminated (Management decision)
First Posted : March 28, 2006
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dry AMD||Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg Other: Anecortave Acetate Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2596 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.
Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg
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.
Sham Comparator: Anecortave Acetate Vehicle
One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye.
Other: Anecortave Acetate Vehicle
One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.
- Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307398
|United States, Texas|
|Study Centers in the United States and Globally|
|Fort Worth, Texas, United States, 76134|
|Study Director:||Patricia Zilliox||Study Manager|