Back to resultsOpen-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
Primary Purpose
Macular Degeneration
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
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, CNV, Anecortave Acetate
Eligibility Criteria
Inclusion Criteria: Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anecortave Acetate, 15 mg
Arm Description
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
Outcomes
Primary Outcome Measures
Percent of patients who maintained stable vision
Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)
Mean change in best-corrected visual acuity at Month 24 from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00065728
Brief Title
Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
Official Title
An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Terminated
Why Stopped
Management decision
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (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 investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.
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, CNV, Anecortave Acetate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anecortave Acetate, 15 mg
Arm Type
Experimental
Arm Description
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
Intervention Description
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
Primary Outcome Measure Information:
Title
Percent of patients who maintained stable vision
Description
Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)
Time Frame
Month 24
Title
Mean change in best-corrected visual acuity at Month 24 from baseline
Time Frame
Baseline, Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Wiernas, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
City
Central Contact Ft. Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
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