NCT00492284

Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: QLT Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.

Conditions

• Choroidal Neovascularization
• Macular Degeneration

Interventions

Type	Name	Description
DRUG	verteporfin	Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
DRUG	verteporfin	Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
DRUG	ranibizumab	0.5 mg intravitreal injection
DRUG	dexamethasone	0.5 mg intravitreal injection

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-05-01
• Completion: 2010-05-01
• First posted: 2007-06-27
• Last updated: 2011-06-02
• Results posted: 2010-06-22

Locations

26 sites across 2 countries: United States, Canada