NCT00436553

Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Conditions

• Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Verteporfin Photodynamic Therapy	After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
DRUG	Ranibizumab	Ranibizumab 0.5 mg administered as an intravitreal injection.
DRUG	Verteporfin Placebo	To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
DRUG	Ranibizumab Placebo	To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-02-19
• Last updated: 2011-04-19
• Results posted: 2011-04-19

Locations

43 sites across 2 countries: United States, Canada