Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

Conditions

• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• aflibercept injection (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
• aflibercept injection (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
• aflibercept injection (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
• aflibercept injection (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
• aflibercept injection (VEGF Trap-Eye, BAY86-5321) — BIOLOGICAL
  Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.

Study Details

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Key Dates

Start date

Apr 30, 2006

Status verified

Jan 2012

Primary completion

Jun 30, 2008

Completion

Aug 31, 2008

Study Design

Enrollment

159 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
• Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
• Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
• Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
• Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12

Primary Outcome Measure

Mean Change of CR/LT From Baseline at Week 12 [ Time Frame: Baseline and at Week 12 ]

Locations (18)

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