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Anecortave Acetate Risk-Reduction Trial (AART)
This study has been completed.
First Received: March 24, 2006   Last Updated: May 7, 2009   History of Changes
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00307398
  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
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Anecortave Acetate Risk-Reduction Trial (AART)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • To demonstrate that anecortave acetate is safe and effective in arresting the progression of dry AMD to wet AMD in at-risk patients

Secondary Outcome Measures:
  • Time to development of sight threatening CNV

Estimated Enrollment: 2500
Study Start Date: March 2004
Estimated Study Completion Date: February 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  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

Exclusion Criteria:

  • Age
  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

Study ID Numbers: C-02-60
Study First Received: March 24, 2006
Last Updated: May 7, 2009
ClinicalTrials.gov Identifier: NCT00307398     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
AMD
Dry AMD
Drusen
CNV

ClinicalTrials.gov processed this record on September 11, 2009