Text Size

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
History of Changes
  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
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 May 23, 2013