Conditions: Macular Degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Detailed description:

Arms:
arm 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. arm 2: Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. arm 3: Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.

Interventions: intervention 1: abicipar pegol intervention 2: ranibizumab intervention 3: sham procedure
Intervention descriptions: intervention 1: Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8. intervention 2: Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. intervention 3: Sham procedure to the study eye at weeks 12 and 16.

Protocol document: