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

Conditions

• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevasiranib — DRUG
  Bevasiranib (2.5mg) administered intravitreally every 8 or 12 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 bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.

Key Dates

First listed

Jul 11, 2007

Start date

Aug 31, 2007

Status verified

Sep 2014

Primary completion

Mar 31, 2009

Completion

May 31, 2009

Study Design

Enrollment

338 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: A
  Lucentis® (0.5mg) every 4 weeks.
• Experimental: B
  Bevasiranib (2.5mg) 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 (2.5mg) every 12 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

Visual Acuity [ Time Frame: week 60 ]

Locations (55)

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