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

Macular Edema Clinical Trial

— COBALT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903720
• Other study ID #: APMA-OZU-01-01
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2013
• Est. completion date: March 30, 2015

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 30, 2015
• Est. primary completion date: September 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 6
Secondary	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.	Baseline, Month 6
Secondary	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.	Baseline, Month 12
Secondary	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.	Baseline, Month 12
Secondary	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.	Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary	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.	Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary	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.	Baseline, Months 6 and 12
Secondary	Percentage of Participants Receiving a Second Injection		12 Months
Secondary	Percentage of Participants Receiving a Third Injection		12 Months
Secondary	Time to Second Injection	Time in weeks from the first injection to the second injection.	12 Months
Secondary	Time to Third Injection	Time in weeks from the second injection to the third injection.	12 Months
Secondary	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.	12 Months