Anecortave Acetate Risk Reduction Trial (AART)

AMD Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00332657
• Other study ID #: C-05-34
• Status: Terminated
• Phase: Phase 3
• First received: May 31, 2006
• Last updated: November 27, 2012
• Start date: September 2006
• Est. completion date: December 2008

Study information

• Verified date: September 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

The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Dry AMD in study eye, Wet AMD non-study eye.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Under 50.

• 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: Prevention

Related Conditions & MeSH terms

• AMD

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 30 mg/mL
One 0.5 mL injection into the PJD at 6-month intervals for 42 months
• Anecortave Acetate Sterile Suspension, 60 mg/mL
One 0.5 mL injection into the PJD at 6-month intervals for 42 months

Other:
• Anecortave Acetate Vehicle
One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

Locations

Country	Name	City	State
India	India	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye		Month 48	No
Secondary	Time to development of sight-threatening CNV		Timepoint	No