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

NCT00499590 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2014-10-06

Study results available
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Summary

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.

Conditions

  • Macular Degeneration

Interventions

DRUG

bevasiranib

Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

DRUG

ranibizumab

Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Denis O'Shaughnessy, Ph.D. · Senior VP of Clincial Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-03-31
Completion
2009-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00499590 on ClinicalTrials.gov