Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

Phase 3

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Anecortave Acetate 15 mg sterile suspension; Other: Photodynamic Therapy (PDT)

• Registration Number: NCT00041483
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-07-09
• Study First Submitted QC: 2002-07-31
• Study First Posted: 2002-08-01
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2008-07
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anecortave and Sham PDT	Anecortave Acetate 15 mg sterile suspension	-
Anecortave and Sham PDT	Photodynamic Therapy (PDT)	-
PDT and Sham Anecortave Acetate	Photodynamic Therapy (PDT)	-
PDT and Sham Anecortave Acetate	Anecortave Acetate 15 mg sterile suspension	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Maintaining Vision	Month 12

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Ft. Worth, Texas, United States