Conditions: Macular Degeneration
Keywords: AMD Macular Degeneration bevasiranib COBALT study age related macular degeneration wet AMD wet age related macular degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 338
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Lucentis® (0.5mg) every 4 weeks. arm 2: Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. arm 3: Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.

Interventions: intervention 1: bevasiranib intervention 2: ranibizumab
Intervention descriptions: intervention 1: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks intervention 2: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Protocol document: