Back to resultsPhase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD
Primary Purpose
Macular Degeneration
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate 15 mg sterile suspension
Photodynamic Therapy (PDT)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, age-related macular degeneration, Anecortave, Acetate, Wet form of age-related macular degeneration
Eligibility Criteria
Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant concomitant diseases will be excluded.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anecortave and Sham PDT
PDT and Sham Anecortave Acetate
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Patients Maintaining Vision
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00041483
Brief Title
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD
Official Title
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, age-related macular degeneration, Anecortave, Acetate, Wet form of age-related macular degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anecortave and Sham PDT
Arm Type
Active Comparator
Arm Title
PDT and Sham Anecortave Acetate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate 15 mg sterile suspension
Intervention Type
Other
Intervention Name(s)
Photodynamic Therapy (PDT)
Primary Outcome Measure Information:
Title
Percentage of Patients Maintaining Vision
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant concomitant diseases will be excluded.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD
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