Anecortave Acetate Risk-Reduction Trial (AART)

Phase 3

Terminated

• Conditions: Dry AMD
• Interventions: Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg; Other: Anecortave Acetate Vehicle

• Registration Number: NCT00307398
• Lead Sponsor: Alcon Research

Brief Summary

A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-03-24
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-28
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-05
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2596

Inclusion Criteria

• Dry AMD study eye, Wet AMD non-study eye.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Age
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-3789	Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg	One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.
Anecortave Acetate Vehicle	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48	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.

Trial Locations

Locations (1)

Study Centers in the United States and Globally; 🇺🇸 Fort Worth, Texas, United States