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

Sponsor:	Opko Health, Inc.
Information provided by:	Opko Health, Inc.
ClinicalTrials.gov Identifier:	NCT00499590

Purpose

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.

Condition	Intervention	Phase
Macular Degeneration	Drug: bevasiranib Drug: ranibizumab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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).

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Opko Health, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	330
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Lucentis® (0.5mg) every 4 weeks.	Drug: ranibizumab Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
B: 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.	Drug: bevasiranib Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
C: 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.	Drug: bevasiranib Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499590

Show 60 Study Locations

Sponsors and Collaborators

Opko Health, Inc.

Investigators

Study Director:

Denis O'Shaughnessy, Ph.D.

Senior VP of Clincial Development

More Information

No publications provided

Responsible Party:	Opko Health ( Denis O'Shaughnessy, PhD Senior VP Clinical Development )
ClinicalTrials.gov Identifier:	NCT00499590 History of Changes
Other Study ID Numbers:	ACU301
Study First Received:	July 10, 2007
Last Updated:	March 10, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Opko Health, Inc.:

AMD
Macular Degeneration
bevasiranib
COBALT study

age related macular degeneration
wet AMD
wet age related macular degeneration

Additional relevant MeSH terms:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 01, 2010