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A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion (COBALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903720
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : July 21, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.

Condition or disease Intervention/treatment Phase
Macular Edema Retinal Vein Occlusion Drug: dexamethasone implant Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 16, 2013
Actual Primary Completion Date : September 24, 2014
Actual Study Completion Date : March 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: OZURDEX®
OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
 Drug: dexamethasone implant
OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Other Name: OZURDEX®


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 [ Time Frame: Baseline, Month 6 ]
    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.


Secondary Outcome Measures :
  1. Change From Baseline in Central Retinal Thickness (CRT) at Month 6 [ Time Frame: Baseline, Month 6 ]
    CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.

  2. Change From Baseline in BCVA at Month 12 [ Time Frame: Baseline, Month 12 ]
    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.

  3. Change From Baseline in CRT at Month 12 [ Time Frame: Baseline, Month 12 ]
    CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.

  4. Change From Baseline in BCVA at Each Visit [ Time Frame: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 ]
    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.

  5. Change From Baseline in CRT at Each Visit [ Time Frame: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 ]
    CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.

  6. Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA [ Time Frame: Baseline, Months 6 and 12 ]
    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.

  7. Percentage of Participants Receiving a Second Injection [ Time Frame: 12 Months ]
  8. Percentage of Participants Receiving a Third Injection [ Time Frame: 12 Months ]
  9. Time to Second Injection [ Time Frame: 12 Months ]
    Time in weeks from the first injection to the second injection.

  10. Time to Third Injection [ Time Frame: 12 Months ]
    Time in weeks from the second injection to the third injection.

  11. Percentage of Participants Who Received Laser Treatments [ Time Frame: 12 Months ]
    Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of macular edema
  • Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

Exclusion Criteria:

  • Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
  • Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
  • Any active ocular infection in either eye
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01903720


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01903720    
Other Study ID Numbers: APMA-OZU-01-01
First Posted: July 19, 2013    Key Record Dates
Results First Posted: July 21, 2016
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents