drugset / Trial / NCT00499590

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

NCT00499590

Phase 3 Terminated 338 enrolled OPKO Health, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-08
Primary completion
2009-03
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal
Subject bevasiranib Unknown 2.5 mg Intravitreal

Indications