NCT00134667

Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)

A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (planned)
• Sponsor: Eyetech Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Photodynamic Therapy (PDT) with Visudyne (verteporfin)
DRUG	Macugen (pegaptanib sodium)

Timeline

• Start date: 2005-03-01
• Completion: 2008-10-01
• First posted: 2005-08-25
• Last updated: 2007-01-15

Locations

1 site across 1 country: United States