NCT00242580

A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib

A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus Intravitreal Pegaptanib(Macugen®) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.

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 to the study eye, begun 15 minutes after the start of infusion.
DRUG	Pegaptanib	Pegaptanib sodium 0.3 mg administered by intravitreal injection.
DRUG	Triamcinolone acetonide	Triamcinolone acetonide administered by intravitreal injection.

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-01-01
• First posted: 2005-10-20
• Last updated: 2016-03-31
• Results posted: 2011-05-02

Locations

1 site across 1 country: United States