Text Size

Anecortave Acetate Risk-Reduction Trial (AART)

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00333216
First received: May 31, 2006
Last updated: November 27, 2012
Last verified: December 2011
History of Changes

May 31, 2006
November 27, 2012
May 2005
December 2008   (final data collection date for primary outcome measure)
Proportion of patients with sight-threatening CNV in study eye [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
Percent of patients with sight-threatening CNV in study eye
Complete list of historical versions of study NCT00333216 on ClinicalTrials.gov Archive Site
  • Time to development of sight-threatening CNV [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ]
  • Proportion of patients with stable vision [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ]
Time to development of sight-threatening CNV and percent patients with stable vision at 24 months, 36 months, and 48 months compared to baseline
Not Provided
Not Provided
 
Anecortave Acetate Risk-Reduction Trial (AART)
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
AMD
  • Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
    Posterior juxtascleral administration of suspension
  • Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML
    Posterior juxtascleral administration of suspension
  • Other: Anecortave Acetate Vehicle
    Sham posterior juxtascleral administration of suspension
  • 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
    Intervention: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
  • 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
    Intervention: Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML
  • Sham Comparator: Anecortave Acetate Vehicle
    Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months
    Intervention: Other: Anecortave Acetate Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00333216
C-04-30
No
Alcon Research
Alcon Research
Not Provided
Study Director: Terry Wiernas, PhD Study Director
Alcon Research
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP