Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)

Macular Degeneration Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299507
• Other study ID #: C-04-59
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2006
• Last updated: November 27, 2012
• Start date: March 2005
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Less than 50 years of age.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 30 mg/mL
One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
• Anecortave Acetate Sterile Suspension, 60 mg/mL
One 0.5 mL posterior juxtascleral depot injection at 6 month intervals

Other:
• Anecortave Acetate Vehicle
One 0.5 mL sham injection at 6 month intervals

Locations

Country	Name	City	State
United States	Alcon Study Sites	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline		Month 12	No
Secondary	Mean change in lesion growth at Month 12 from baseline		Month 12	No