- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332657
Anecortave Acetate Risk Reduction Trial (AART)
November 27, 2012 updated by: Alcon Research
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
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Bangalore, India, 76134
- India
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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 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.
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: 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.
|
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.
|
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.
|
One 0.5 mL sham injection at 6-month intervals for 42 months.
Syringe and vehicle were not inserted into the eye.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with sight-threatening choroidal neovascularization (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: Timepoint
|
Timepoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2006
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
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-05-34
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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