- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346957
A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration
March 3, 2012 updated by: Alcon Research
The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 2
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:
- Ages 50 years and over
- Other protocol-defined inclusion and 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 |
---|---|
Placebo Comparator: Anecortave Acetate Vehicle
|
0.5ml administered onto the sclera once every six months for 24 months
|
Experimental: Anecortave Acetate 30
|
0.5ml administered onto the sclera once every six months for 24 months
|
Experimental: Anecortave Acetate 15
|
0.5ml administered onto the sclera once every six months for 24 months
|
Experimental: Anecortave Acetate 3
|
0.5ml administered onto the sclera once every six months for 24 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in logMAR visual acuity at 12 months from baseline.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 1999
Primary Completion (Actual)
April 1, 2003
Study Completion (Actual)
April 1, 2003
Study Registration Dates
First Submitted
June 28, 2006
First Submitted That Met QC Criteria
June 30, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
March 6, 2012
Last Update Submitted That Met QC Criteria
March 3, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-98-03
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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