Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (COBALT)
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ClinicalTrials.gov Identifier: NCT00499590 |
Recruitment Status :
Terminated
First Posted : July 11, 2007
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Macular Degeneration | Drug: bevasiranib Drug: ranibizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 338 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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). |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
Lucentis® (0.5mg) every 4 weeks.
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Drug: ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Other Name: 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.
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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.
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Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks |
- Visual Acuity [ Time Frame: week 60 ]avoidance of 3 or more lines of vision loss
- 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 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499590

Study Director: | Denis O'Shaughnessy, Ph.D. | Senior VP of Clincial Development |
Responsible Party: | OPKO Health, Inc. |
ClinicalTrials.gov Identifier: | NCT00499590 |
Other Study ID Numbers: |
ACU301 |
First Posted: | July 11, 2007 Key Record Dates |
Results First Posted: | October 6, 2014 |
Last Update Posted: | October 6, 2014 |
Last Verified: | September 2014 |
AMD Macular Degeneration bevasiranib COBALT study |
age related macular degeneration wet AMD wet age related macular degeneration |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |