Anecortave Acetate Risk-Reduction Trial (AART)

This study has been terminated.
(Management decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00307398
First received: March 24, 2006
Last updated: November 27, 2012
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Dry AMD
Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg
Other: Anecortave Acetate Vehicle
Phase 3

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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2596
Study Start Date: March 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-3789
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307398

Locations
United States, Texas
Study Centers in the United States and Globally
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Patricia Zilliox Study Manager
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00307398     History of Changes
Other Study ID Numbers: C-02-60
Study First Received: March 24, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
AMD
Dry AMD
Drusen
CNV

ClinicalTrials.gov processed this record on July 22, 2014