Macular DegenerationPhase 3COBALTNCT00499590
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
A Phase 3 study testing bevasiranib and ranibizumab in people with Macular Degeneration, run by OPKO Health, Inc. at 60 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- bevasiranib and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 60 sitesin 2 countries
- Study dates
- Aug 2007to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
60 sites in 2 countries.
60 sites in 2 countries
United States55 sites
Retina Research Institute of Texas, L.L.C. (site 269)
Abilene, Texas, 79606
Capital Region Retina (site 316)
Albany, New York, 12206
Florida Eye Clinic (site 257)
Altamonte Springs, Florida, 32701
Retina and Vitreous Center of Southern Oregon (site 271)
Ashland, Oregon, 97520
Southeast Retina Center (site 268)
Augusta, Georgia, 30909
Austin Retina Associates (site 304)
Austin, Texas, 78705
Retina Research Center (site 204)
Austin, Texas, 78705
Ophthalmology Associates of PA (site 297)
Bala-Cynwyd, Pennsylvania, 19004
Retina Associates of Cleveland (site 228)
Beachwood, Ohio, 44122
Florida Eye Microsurgical Institute, Inc. (site 217)
Boynton Beach, Florida, 33426
University of Virginia- Ophthalmology Dept. (site 254)
Charlottesville, Virginia, 22908
Cincinnati Eye Institute (site 285)
Cincinnati, Ohio, 45242
Retina Associates St. Louis (site 300)
Florissant, Missouri, 63031
Retina Health Center (site 247)
Fort Myers, Florida, 33901
National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)
Fort Myers, Florida, 33912
Eye Medical Center (site 287)
Fresno, California, 93720
University of Texas Medical Branch- Galveston (site 301
Galveston, Texas, 77555
Houston Eye Associates (site 321)
Houston, Texas, 77025
Midwest Eye Institute (site 253)
Indianapolis, Indiana, 46280
Eye Foundation of Kansas City Truman Medical Center (site 272)
Kansas City, Missouri, 64108
Southeastern Retina Associates, PC (Site 250)
Knoxville, Tennessee, 37909
Retina Associates of Cleveland, Inc. (site 219)
Lakewood, Ohio, 44107
Retinal Consultants of Nevada (site 273)
Las Vegas, Nevada, 89144
Delaware Valley Retina Associates (site 261)
Lawrenceville, New Jersey, 08648
Retina-Vitreous Consultants (site 216)
Livingston, New Jersey, 07039
Eye Centers of Louisville (site 251)
Louisville, Kentucky, 40207
Valley Retina Institue, PA (site 258)
McAllen, Texas, 78503
Northern California Retina Vitreous Associates (site 320)
Mountain View, California, 94040
New York Eye & Ear Infirmary (site 272)
New York, New York, 10003
Vitreous-Retina-Macula Consultants of New York (site 239)
New York, New York, 10022
Magruder Eye Institute (site 264)
Orlando, Florida, 32803
Retina Institute of California (site 207)
Pasadena, California, 91105
Retinal Consultants of Arizona (site 209)
Phoenix, Arizona, 85014
Associated Retina Consultants (site 286)
Phoenix, Arizona, 85020
Eyesight Ophthalmic Services, PA (site 290)
Portsmouth, New Hampshire, 03801
Retina Consultants San Diego (site 232)
Poway, California, 93064
Black Hills Regional Eye Institute (site 202)
Rapid City, South Dakota, 57701
Retinal Consultants Medical Group (site 289)
Sacramento, California, 95819
Rocky Mountain Retina Consultants (site 256)
Salt Lake City, Utah, 84107
University of Utah, John A. Moran Eye Center (site 205)
Salt Lake City, Utah, 84132
Orange County Retina Medical Group (site 252)
Santa Ana, California, 92705
Retina Associates, PA (site 295)
Shawnee Mission, Kansas, 66204
Carolina Eye Associates (site 308)
Southern Pines, North Carolina, 28387
Southern Vitreoretinal Associates, PL (site 309)
Tallahassee, Florida, 32308
University of South Florida Eye Institute (site 311)
Tampa, Florida, 33612
Retina Associates of New Jersey (site 298)
Teaneck, New Jersey, 07666
Retina-Vitreous Associates (site 266)
Toledo, Ohio, 43608
Retina Specialists (site 231)
Towson, Maryland, 21204
Retina Centers PC (site 215)
Tucson, Arizona, 85704
Eye Care Associates of East Texas (site 282)
Tyler, Texas, 75701
Miramar Eye Specialists Medical Group (site 245)
Ventura, California, 93003
The Eye Care Group, PC (site 315)
Waterbury, Connecticut, 06708
Palmetto Retina Center (site 275)
West Columbia, South Carolina, 29169
Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
Wichita, Kansas, 67214
Center for Retina and Macular Disease (site 293)
Winter Haven, Florida, 33880
Canada5 sites
Calgary Retina Consultants (site 318)
Calgary, Alberta, T3E 7M8
Ivey Eye Institute (site 314)
London, Ontario, N6A 4G5
Canadian Centre for Advanced Eye Therapeutics (site 291)
Mississauga, Ontario, L4W 1W9
Eye Centre Pasqua Hospital (site 299)
Regina, Saskatchewan, S4T 1A5
Sunnybrook Health Sciences Centre (site 305)
Toronto, Ontario, M4N 3M5
About this study
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).
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
- Being tested
- bevasiranib, ranibizumab
- Keywords
- AMD, Macular Degeneration, bevasiranib, COBALT study, age related macular degeneration, wet AMD, wet age related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevasiranibDrug
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
ranibizumabDrug
Also called Lucentis®
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Lucentis® (0.5mg) every 4 weeks. Receives: Drug: ranibizumab |
| 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. Receives: Drug: bevasiranib |
| 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. Receives: Drug: bevasiranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
avoidance of 3 or more lines of vision loss
Measured: week 60
Secondary outcomes (1)
Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision
Measured: Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis O'Shaughnessy, Ph.D., Study director, Senior VP of Clincial Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499590
- Sponsor's protocol ID
- ACU301
- Acronym
- COBALT
- Status last verified
- Sep 2014
- First submitted
- 10 Jul 2007
- Last updated
- 6 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00499590
- Acronym / sponsor ID
- COBALT / ACU301
- Conditions
- Macular Degeneration
- Keywords
- AMD, Macular Degeneration, bevasiranib, COBALT study, age related macular degeneration, wet AMD, wet age related macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 338 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ranibizumabLucentis® (0.5mg) every 4 weeks. |
| B | Experimental | Drug: bevasiranibBevasiranib (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. |
| C | Experimental | Drug: bevasiranibBevasiranib (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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevasiranibBevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks | Drug | B, C |
| ranibizumabAlso: Lucentis®Lucentis® (0.5 mg)administered intravitreally every 4 weeks. | Drug | A |
Primary outcome
Visual Acuity
Time frame: week 60
avoidance of 3 or more lines of vision loss
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis O'Shaughnessy, Ph.D. study director
Senior VP of Clincial Development
60 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevasiranib and ranibizumab in people with Macular Degeneration, run by OPKO Health, Inc. at 60 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.