NCT00499590

Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD

A Phase 3, Randomized, Double-masked, Parallel-assignment Study of Intravitreal Bevasiranib Sodium, Administered Every 8 or 12 Weeks as Maintenance Therapy Following Three Injections of Lucentis® Compared With Lucentis® Monotherapy Every 4 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD).

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	bevasiranib	Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
DRUG	ranibizumab	Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2007-07-11
• Last updated: 2014-10-06
• Results posted: 2014-10-06

Locations

60 sites across 2 countries: United States, Canada