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Anecortave Acetate Risk-Reduction Trial (AART)

This study has been terminated.
(Lack of efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333216
First Posted: June 2, 2006
Last Update Posted: November 29, 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
The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.

Condition Intervention Phase
AMD Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML Other: Anecortave Acetate Vehicle Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) Versus Sham Administration in Singaporean Patients at Risk for Progressing to Exudative Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of patients with sight-threatening CNV in study eye [ Time Frame: Month 48 ]

Secondary Outcome Measures:
  • Time to development of sight-threatening CNV [ Time Frame: Up to 48 months ]
  • Proportion of patients with stable vision [ Time Frame: Up to 48 months ]

Enrollment: 24
Study Start Date: May 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
Posterior juxtascleral administration of suspension
Experimental: 30 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months
Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML
Posterior juxtascleral administration of suspension
Sham Comparator: Anecortave Acetate Vehicle
Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months
Other: Anecortave Acetate Vehicle
Sham posterior juxtascleral administration of suspension

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dry AMD in study eye, Wet AMD in non-study eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 50;
  • 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): NCT00333216


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Terry Wiernas, PhD Study Director
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333216     History of Changes
Other Study ID Numbers: C-04-30
First Submitted: May 31, 2006
First Posted: June 2, 2006
Last Update Posted: November 29, 2012
Last Verified: December 2011

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