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

Primary Purpose

Macular Degeneration

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bevasiranib
ranibizumab
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Macular Degeneration, bevasiranib, COBALT study, age related macular degeneration, wet AMD, wet age related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retinal Consultants of Arizona (site 209)
  • Associated Retina Consultants (site 286)
  • Retina Centers PC (site 215)
  • Eye Medical Center (site 287)
  • Northern California Retina Vitreous Associates (site 320)
  • Retina Institute of California (site 207)
  • Retina Consultants San Diego (site 232)
  • Retinal Consultants Medical Group (site 289)
  • Orange County Retina Medical Group (site 252)
  • Miramar Eye Specialists Medical Group (site 245)
  • The Eye Care Group, PC (site 315)
  • Florida Eye Clinic (site 257)
  • Florida Eye Microsurgical Institute, Inc. (site 217)
  • Retina Health Center (site 247)
  • National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)
  • Magruder Eye Institute (site 264)
  • Southern Vitreoretinal Associates, PL (site 309)
  • University of South Florida Eye Institute (site 311)
  • Center for Retina and Macular Disease (site 293)
  • Southeast Retina Center (site 268)
  • Midwest Eye Institute (site 253)
  • Retina Associates, PA (site 295)
  • Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
  • Eye Centers of Louisville (site 251)
  • Retina Specialists (site 231)
  • Retina Associates St. Louis (site 300)
  • Eye Foundation of Kansas City Truman Medical Center (site 272)
  • Retinal Consultants of Nevada (site 273)
  • Eyesight Ophthalmic Services, PA (site 290)
  • Delaware Valley Retina Associates (site 261)
  • Retina-Vitreous Consultants (site 216)
  • Retina Associates of New Jersey (site 298)
  • Capital Region Retina (site 316)
  • New York Eye & Ear Infirmary (site 272)
  • Vitreous-Retina-Macula Consultants of New York (site 239)
  • Carolina Eye Associates (site 308)
  • Retina Associates of Cleveland (site 228)
  • Cincinnati Eye Institute (site 285)
  • Retina Associates of Cleveland, Inc. (site 219)
  • Retina-Vitreous Associates (site 266)
  • Retina and Vitreous Center of Southern Oregon (site 271)
  • Ophthalmology Associates of PA (site 297)
  • Palmetto Retina Center (site 275)
  • Black Hills Regional Eye Institute (site 202)
  • Southeastern Retina Associates, PC (Site 250)
  • Retina Research Institute of Texas, L.L.C. (site 269)
  • Austin Retina Associates (site 304)
  • Retina Research Center (site 204)
  • University of Texas Medical Branch- Galveston (site 301
  • Houston Eye Associates (site 321)
  • Valley Retina Institue, PA (site 258)
  • Eye Care Associates of East Texas (site 282)
  • Rocky Mountain Retina Consultants (site 256)
  • University of Utah, John A. Moran Eye Center (site 205)
  • University of Virginia- Ophthalmology Dept. (site 254)
  • Calgary Retina Consultants (site 318)
  • Ivey Eye Institute (site 314)
  • Canadian Centre for Advanced Eye Therapeutics (site 291)
  • Sunnybrook Health Sciences Centre (site 305)
  • Eye Centre Pasqua Hospital (site 299)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Lucentis® (0.5mg) every 4 weeks.

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.

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.

Outcomes

Primary Outcome Measures

Visual Acuity
avoidance of 3 or more lines of vision loss

Secondary Outcome Measures

Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision

Full Information

First Posted
July 10, 2007
Last Updated
September 29, 2014
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00499590
Brief Title
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Acronym
COBALT
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Macular Degeneration, bevasiranib, COBALT study, age related macular degeneration, wet AMD, wet age related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Lucentis® (0.5mg) every 4 weeks.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
Arm Title
C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bevasiranib
Intervention Description
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
avoidance of 3 or more lines of vision loss
Time Frame
week 60
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis O'Shaughnessy, Ph.D.
Organizational Affiliation
Senior VP of Clincial Development
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona (site 209)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Associated Retina Consultants (site 286)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina Centers PC (site 215)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Eye Medical Center (site 287)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Northern California Retina Vitreous Associates (site 320)
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Institute of California (site 207)
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Retina Consultants San Diego (site 232)
City
Poway
State/Province
California
ZIP/Postal Code
93064
Country
United States
Facility Name
Retinal Consultants Medical Group (site 289)
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Orange County Retina Medical Group (site 252)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Miramar Eye Specialists Medical Group (site 245)
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
The Eye Care Group, PC (site 315)
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Florida Eye Clinic (site 257)
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc. (site 217)
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Retina Health Center (site 247)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Magruder Eye Institute (site 264)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Southern Vitreoretinal Associates, PL (site 309)
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
University of South Florida Eye Institute (site 311)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Center for Retina and Macular Disease (site 293)
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center (site 268)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Midwest Eye Institute (site 253)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Retina Associates, PA (site 295)
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Eye Centers of Louisville (site 251)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Retina Specialists (site 231)
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Retina Associates St. Louis (site 300)
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Eye Foundation of Kansas City Truman Medical Center (site 272)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Retinal Consultants of Nevada (site 273)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Eyesight Ophthalmic Services, PA (site 290)
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Delaware Valley Retina Associates (site 261)
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Retina-Vitreous Consultants (site 216)
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Retina Associates of New Jersey (site 298)
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Capital Region Retina (site 316)
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York Eye & Ear Infirmary (site 272)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Vitreous-Retina-Macula Consultants of New York (site 239)
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Carolina Eye Associates (site 308)
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Retina Associates of Cleveland (site 228)
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Cincinnati Eye Institute (site 285)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina Associates of Cleveland, Inc. (site 219)
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Retina-Vitreous Associates (site 266)
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Retina and Vitreous Center of Southern Oregon (site 271)
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Ophthalmology Associates of PA (site 297)
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Palmetto Retina Center (site 275)
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Black Hills Regional Eye Institute (site 202)
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Southeastern Retina Associates, PC (Site 250)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Retina Research Institute of Texas, L.L.C. (site 269)
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Retina Associates (site 304)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center (site 204)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Texas Medical Branch- Galveston (site 301
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Eye Associates (site 321)
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Valley Retina Institue, PA (site 258)
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Eye Care Associates of East Texas (site 282)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Rocky Mountain Retina Consultants (site 256)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah, John A. Moran Eye Center (site 205)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia- Ophthalmology Dept. (site 254)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Calgary Retina Consultants (site 318)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 7M8
Country
Canada
Facility Name
Ivey Eye Institute (site 314)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Canadian Centre for Advanced Eye Therapeutics (site 291)
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre (site 305)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Eye Centre Pasqua Hospital (site 299)
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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