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Anecortave Acetate Risk-Reduction Trial (AART)

This study has been terminated.
(Management decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307398
First Posted: March 28, 2006
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00307398     History of Changes
Other Study ID Numbers: C-02-60
First Submitted: March 24, 2006
First Posted: March 28, 2006
Last Update Posted: November 28, 2012
Last Verified: May 2009

Keywords provided by Alcon Research:
AMD
Dry AMD
Drusen
CNV

Additional relevant MeSH terms:
Anecortave
Hydrocortisone
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents