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OpenTrials
Completed

NCT Number: NCT01568021

Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glostrup Municipality, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Macular Edema
  • Prescribed OZURDEX®

Exclusion criteria

  • None

Treatment and study plan

No intervention

Other

No intervention was administered in this study.

Primary outcomes

  1. Time to First Re-treatment

    Time frame: 1 Year

    Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.

Secondary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) Score

    Time frame: Baseline, Weeks 12, 24 and 48

    BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.

  2. Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)

    Time frame: Baseline, Weeks 12, 24 and 48

    Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2012
Registry last updated
Feb 10, 2015

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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