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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333216     History of Changes
Other Study ID Numbers: C-04-30
Study First Received: May 31, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration
Singapore: Ministry of Health

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014