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

September 29, 2014 updated by: OPKO Health, Inc.

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
338

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 7M8
        • Calgary Retina Consultants (site 318)
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Ivey Eye Institute (site 314)
      • Mississauga, Ontario, Canada, L4W 1W9
        • Canadian Centre for Advanced Eye Therapeutics (site 291)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre (site 305)
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Eye Centre Pasqua Hospital (site 299)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona (site 209)
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants (site 286)
      • Tucson, Arizona, United States, 85704
        • Retina Centers PC (site 215)
    • California
      • Fresno, California, United States, 93720
        • Eye Medical Center (site 287)
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates (site 320)
      • Pasadena, California, United States, 91105
        • Retina Institute of California (site 207)
      • Poway, California, United States, 93064
        • Retina Consultants San Diego (site 232)
      • Sacramento, California, United States, 95819
        • Retinal Consultants Medical Group (site 289)
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group (site 252)
      • Ventura, California, United States, 93003
        • Miramar Eye Specialists Medical Group (site 245)
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • The Eye Care Group, PC (site 315)
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Florida Eye Clinic (site 257)
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute, Inc. (site 217)
      • Fort Myers, Florida, United States, 33901
        • Retina Health Center (site 247)
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)
      • Orlando, Florida, United States, 32803
        • Magruder Eye Institute (site 264)
      • Tallahassee, Florida, United States, 32308
        • Southern Vitreoretinal Associates, PL (site 309)
      • Tampa, Florida, United States, 33612
        • University of South Florida Eye Institute (site 311)
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease (site 293)
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center (site 268)
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Midwest Eye Institute (site 253)
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Retina Associates, PA (site 295)
      • Wichita, Kansas, United States, 67214
        • Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Eye Centers of Louisville (site 251)
    • Maryland
      • Towson, Maryland, United States, 21204
        • Retina Specialists (site 231)
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Retina Associates St. Louis (site 300)
      • Kansas City, Missouri, United States, 64108
        • Eye Foundation of Kansas City Truman Medical Center (site 272)
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Retinal Consultants of Nevada (site 273)
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Eyesight Ophthalmic Services, PA (site 290)
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Delaware Valley Retina Associates (site 261)
      • Livingston, New Jersey, United States, 07039
        • Retina-Vitreous Consultants (site 216)
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey (site 298)
    • New York
      • Albany, New York, United States, 12206
        • Capital Region Retina (site 316)
      • New York, New York, United States, 10003
        • New York Eye & Ear Infirmary (site 272)
      • New York, New York, United States, 10022
        • Vitreous-Retina-Macula Consultants of New York (site 239)
    • North Carolina
      • Southern Pines, North Carolina, United States, 28387
        • Carolina Eye Associates (site 308)
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland (site 228)
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute (site 285)
      • Lakewood, Ohio, United States, 44107
        • Retina Associates of Cleveland, Inc. (site 219)
      • Toledo, Ohio, United States, 43608
        • Retina-Vitreous Associates (site 266)
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Retina and Vitreous Center of Southern Oregon (site 271)
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Ophthalmology Associates of PA (site 297)
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center (site 275)
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute (site 202)
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Southeastern Retina Associates, PC (Site 250)
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas, L.L.C. (site 269)
      • Austin, Texas, United States, 78705
        • Austin Retina Associates (site 304)
      • Austin, Texas, United States, 78705
        • Retina Research Center (site 204)
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch- Galveston (site 301
      • Houston, Texas, United States, 77025
        • Houston Eye Associates (site 321)
      • McAllen, Texas, United States, 78503
        • Valley Retina Institue, PA (site 258)
      • Tyler, Texas, United States, 75701
        • Eye Care Associates of East Texas (site 282)
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants (site 256)
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, John A. Moran Eye Center (site 205)
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia- Ophthalmology Dept. (site 254)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)
  2. Any intraocular surgery of the study eye within 12 weeks of screening
  3. Previous posterior vitrectomy of the study eye
  4. Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
Lucentis® (0.5mg) every 4 weeks.
Drug: ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Other Names:
  • Lucentis®
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.
Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
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.
Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: week 60
avoidance of 3 or more lines of vision loss
week 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OPKO Health, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Denis O'Shaughnessy, Ph.D., Senior VP of Clincial Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACU301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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