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

Tracking Information

First Received Date ^ICMJE

July 10, 2007

Last Updated Date

March 10, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Acuity [ Time Frame: week 60 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Visual Acuity [ Time Frame: week 60 ]

Change History

Complete list of historical versions of study NCT00499590 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Need for Rescue Therapy, Time to Rescue Therapy, and Number of patients with a 3 or more line gain in vision [ Time Frame: Week 60 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Need for Rescue Therapy, Time to Rescue Therapy, and Number of patients with a 3 or more line gain in vision [ Time Frame: Week 60 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 3, Randomized, Double-Masked, Parallel-Assignment Study of Intravitreal Bevasiranib Sodium, Administered Every 8 or 12 Weeks as Maintenance Therapy Following Three Injections of Lucentis® Compared With Lucentis® Monotherapy Every 4 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD).

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: bevasiranib
Drug: ranibizumab

Study Arms / Comparison Groups

Active Comparator: Lucentis® (0.5mg) every 4 weeks.
Experimental: 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: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

330

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must be age 50 years or older
Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.

Exclusion Criteria:

Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye)
Any intraocular surgery of the study eye within 12 weeks of screening
Previous posterior vitrectomy of the study eye
Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00499590

Responsible Party

Denis O'Shaughnessy, PhD Senior VP Clinical Development, Opko Health

Study ID Numbers ^ICMJE

ACU301

Study Sponsor ^ICMJE

Opko Health, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Denis O'Shaughnessy, Ph.D.

Senior VP of Clincial Development

Information Provided By

Opko Health, Inc.

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP