Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)
Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)
1 other identifier
interventional
240
1 country
1
Brief Summary
The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 3, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedNovember 28, 2012
September 1, 2009
3.1 years
March 3, 2006
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
Month 12
Secondary Outcomes (1)
Mean change in lesion growth at Month 12 from baseline
Month 12
Study Arms (4)
15 mg Anecortave Acetate, 3 month intervals
EXPERIMENTALAnecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months).
15 mg Anecortave Acetate, 6 month intervals
EXPERIMENTALAnecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
30 mg Anecortave Acetate, 6 month intervals
EXPERIMENTALAnecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
Anecortave Acetate Vehicle
SHAM COMPARATOROne 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).
Interventions
One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
One 0.5 mL posterior juxtascleral depot injection at 6 month intervals
One 0.5 mL sham injection at 6 month intervals
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
You may not qualify if:
- Less than 50 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Study Sites
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alcon Investigators
Alcon Research
- STUDY DIRECTOR
Patricia Zilliox, Ph.D.
Alcon Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2006
First Posted
March 7, 2006
Study Start
March 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 28, 2012
Record last verified: 2009-09