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Completed

NCT Number: NCT01903720

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

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.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone implant

Drug

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 names: OZURDEX®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: COBALT

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 19, 2013
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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