Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)

Sponsor
OPKO Health, Inc.
Study ID
NCT00557791
Phase
PHASE3
Status
Withdrawn

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Bevasiranib — DRUG
    Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
  • ranibizumab — DRUG
    Lucentis® (0.5 mg) administered intravitreally every 4 weeks.

Study Details

The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.

Key Dates

First listed
Nov 14, 2007
Start date
Nov 30, 2009
Status verified
Feb 2011
Primary completion
Jul 31, 2011
Completion
Jul 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    Lucentis® (0.5 mg) every 4 weeks.
  • Experimental: B
    Bevasiranib (1.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
  • Experimental: C
    Bevasiranib (2.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
  • Experimental: D
    Bevasiranib (2.5 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.

Primary Outcome Measure

Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision). [ Time Frame: 60 weeks ]

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