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

Phase 3

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL; Other: Anecortave Acetate Vehicle

• Registration Number: NCT00299507
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-03-03
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-09
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mg Anecortave Acetate, 3 month intervals	Anecortave Acetate Sterile Suspension, 30 mg/mL	Anecortave 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	Anecortave Acetate Sterile Suspension, 30 mg/mL	Anecortave 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	Anecortave Acetate Sterile Suspension, 60 mg/mL	Anecortave 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	Anecortave Acetate Vehicle	One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).

Primary Outcome Measures

Name	Time	Method
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline	Month 12

Secondary Outcome Measures

Name	Time	Method
Mean change in lesion growth at Month 12 from baseline	Month 12

Trial Locations

Locations (1)

Alcon Study Sites; 🇺🇸 Fort Worth, Texas, United States