Conditions: Macular Degeneration
Keywords: Eye diseases Vision Impairment and Blindness Eyes and Vision Seniors Neovascular Age-Related Macular Degeneration (AMD) Retinal Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1240
Healthy volunteers: no

Brief summary:
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

Detailed description:
Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.

Arms:
arm 1: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 2: Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 3: Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 4: Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Interventions: intervention 1: Ranibizumab intervention 2: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) intervention 3: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) intervention 4: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intervention descriptions: intervention 1: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 2: Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 3: Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 4: Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Protocol document: