- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00307398
Anecortave Acetate Risk-Reduction Trial (AART)
November 27, 2012 updated by: Alcon Research
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2596
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
-
-
Texas
-
Fort Worth, Texas, United States, 76134
- Study Centers in the United States and Globally
-
-
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dry AMD study eye, Wet AMD non-study eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Age
- 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AL-3789
One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.
|
One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.
|
Sham Comparator: Anecortave Acetate Vehicle
One sham injection to the study eye at 6-month intervals for 42 months.
Syringe containing AA vehicle was not inserted into the eye.
|
One 0.5 mL sham injection at 6-month intervals.
Syringe containing AA vehicle was not inserted into the eye.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48
Time Frame: Month 48
|
ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.
|
Month 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Patricia Zilliox, Study Manager
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
March 1, 2004
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
March 24, 2006
First Submitted That Met QC Criteria
March 24, 2006
First Posted (Estimate)
March 28, 2006
Study Record Updates
Last Update Posted (Estimate)
November 28, 2012
Last Update Submitted That Met QC Criteria
November 27, 2012
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-02-60
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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