Back to resultsA Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion (COBALT)
Primary Purpose
Macular Edema, Retinal Vein Occlusion
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexamethasone implant
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OZURDEX®
Arm Description
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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
Change From Baseline in Central Retinal Thickness (CRT) at 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.
Change From Baseline in BCVA at 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.
Change From Baseline in CRT at 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.
Change From Baseline in BCVA at Each Visit
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.
Change From Baseline in CRT at Each Visit
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.
Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA
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.
Percentage of Participants Receiving a Second Injection
Percentage of Participants Receiving a Third Injection
Time to Second Injection
Time in weeks from the first injection to the second injection.
Time to Third Injection
Time in weeks from the second injection to the third injection.
Percentage of Participants Who Received Laser Treatments
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01903720
Brief Title
A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
Acronym
COBALT
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 16, 2013 (Actual)
Primary Completion Date
September 24, 2014 (Actual)
Study Completion Date
March 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OZURDEX®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dexamethasone implant
Other Intervention Name(s)
OZURDEX®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
Description
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.
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Central Retinal Thickness (CRT) at Month 6
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in BCVA at Month 12
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in CRT at Month 12
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in BCVA at Each Visit
Description
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.
Time Frame
Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Title
Change From Baseline in CRT at Each Visit
Description
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.
Time Frame
Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Title
Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA
Description
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.
Time Frame
Baseline, Months 6 and 12
Title
Percentage of Participants Receiving a Second Injection
Time Frame
12 Months
Title
Percentage of Participants Receiving a Third Injection
Time Frame
12 Months
Title
Time to Second Injection
Description
Time in weeks from the first injection to the second injection.
Time Frame
12 Months
Title
Time to Third Injection
Description
Time in weeks from the second injection to the third injection.
Time Frame
12 Months
Title
Percentage of Participants Who Received Laser Treatments
Description
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.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29642062
Citation
Yoon YH, Kim JW, Lee JY, Kim IT, Kang SW, Yu HG, Koh HJ, Kim SS, Chang DJ, Simonyi S. Dexamethasone Intravitreal Implant for Early Treatment and Retreatment of Macular Edema Related to Branch Retinal Vein Occlusion: The Multicenter COBALT Study. Ophthalmologica. 2018;240(2):81-89. doi: 10.1159/000487547. Epub 2018 Apr 11.
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A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
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