Anecortave Acetate Risk Reduction Trial (AART)

This study has been terminated.
(Management Decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00332657
First received: May 31, 2006
Last updated: November 27, 2012
Last verified: September 2009
  Purpose

The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.


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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of patients with sight-threatening choroidal neovascularization (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: Timepoint ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anecortave Acetate, 15 mg
One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
One 0.5 mL injection into the PJD at 6-month intervals for 42 months
Experimental: Anecortave Acetate, 30 mg
One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.
Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
One 0.5 mL injection into the PJD at 6-month intervals for 42 months
Sham Comparator: Anecortave Acetate Vehicle
One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.
Other: Anecortave Acetate Vehicle
One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

  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 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: NCT00332657

Locations
India
India
Bangalore, India, 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: NCT00332657     History of Changes
Other Study ID Numbers: C-05-34
Study First Received: May 31, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014