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

Conditions

• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — BIOLOGICAL
  Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection 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 (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received a 2.0mg dose of aflibercept injection 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 (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received a 0.5mg dose of aflibercept injection 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 (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. 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 3, 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 the US and Canada.

Key Dates

Start date

Aug 31, 2007

Status verified

Dec 2012

Primary completion

Sep 30, 2010

Completion

Jul 31, 2011

Study Design

Enrollment

1,217 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ranibizumab 0.5mg Q4
• Experimental: aflibercept injection 2.0mg Q4
• Experimental: aflibercept injection 0.5mg Q4
• Experimental: aflibercept injection 2.0mg Q8

Primary Outcome Measure

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

Locations (176)

Find similar trials in Birmingham, AL

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