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OpenTrials
Completed

NCT Number: NCT01618266

Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion

Epidemiological study of Ozurdex® in sites treating patients with 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

Observational

Primary location

Paris, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Macular oedema due to retinal vein occlusion

Exclusion criteria

  • Not living in metropolitan France

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.

Other names: Ozurdex®

Primary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    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 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 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.

Secondary outcomes

  1. Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)

    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 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 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. BRVO is a blockage of the small veins in the retina.

  2. Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)

    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 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 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. CRVO is a blockage of the main vein in the retina.

  3. Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients

    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 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 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. Treatment naïve patients have not been previously treated for retinal vein occlusion.

  4. Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®

    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 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 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. Previous treatment for retinal vein occlusion was Ozurdex®.

  5. Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment

    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 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 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. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.

  6. Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months

    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 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 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. The onset of macular edema was <3 months prior to treatment.

  7. Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months

    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 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 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. The onset of macular edema was ≥3 months prior to treatment.

  8. Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®

    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 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 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. Patients had only been previously treated with Ozurdex®.

  9. Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments

    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 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 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. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.

  10. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Week 6, Month 4, Month 12, Month 18, Month 24

    BCVA is measured in the study eye using an eye chart and is 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 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.

  11. Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye

    Time frame: Baseline, Month 24

    BCVA is measured in the study eye using an eye chart and is 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). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 13, 2012
Registry last updated
Mar 14, 2016

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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