Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

Sponsor
Bayer
Study ID
NCT00637377
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    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.
  • Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
    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.
  • Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
    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.
  • Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2008
Status verified
Nov 2014
Primary completion
Sep 30, 2010
Completion
Aug 31, 2011

Study Design

Enrollment
1,240 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ranibizumab 0.5mg Q4
    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.
  • Experimental: Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
    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.
  • Experimental: Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
    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.
  • Experimental: Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
    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.

Primary Outcome Measure

Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: At week 52 ]

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