Anecortave Acetate Risk-Reduction Trial (AART)

Dry AMD Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00307398
• Other study ID #: C-02-60
• Status: Terminated
• Phase: Phase 3
• First received: March 24, 2006
• Last updated: November 27, 2012
• Start date: March 2004
• Est. completion date: January 2009

Study information

• Verified date: May 2009
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2596
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry AMD

Intervention

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.

Other:
• Anecortave Acetate Vehicle
One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.

Locations

Country	Name	City	State
United States	Study Centers in the United States and Globally	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at 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.	Month 48	No