Anecortave Acetate Risk-Reduction Trial (AART)

November 27, 2012 updated by: Alcon Research

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with sight-threatening CNV in study eye
Time Frame: Month 48
Month 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to development of sight-threatening CNV
Time Frame: Up to 48 months
Up to 48 months
Proportion of patients with stable vision
Time Frame: Up to 48 months
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Terry Wiernas, PhD, Study Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria

May 31, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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