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Anecortave Acetate Risk Reduction Trial (AART)

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ClinicalTrials.gov Identifier: NCT00332657
Recruitment Status : Terminated (Management Decision)
First Posted : June 2, 2006
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye [ Time Frame: Month 48 ]

Secondary Outcome Measures :
  1. Time to development of sight-threatening CNV [ Time Frame: Timepoint ]


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 non-study eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 50.
  • Other protocol-defined exclusion criteria may apply.

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): NCT00332657


Locations
India
India
Bangalore, India, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Terry Wiernas, PhD Study Director

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00332657     History of Changes
Other Study ID Numbers: C-05-34
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: September 2009

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