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Completed

NCT Number: NCT01566526

Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
  • Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

Exclusion criteria

  • None

Treatment and study plan

dexamethasone intravitreal implant 0.7 mg

Drug

OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Other names: OZURDEX®

Primary outcomes

  1. Time to OZURDEX® Re-Injection in the Study Eye

    Time frame: Up to 12 Months

    The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.

Secondary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye

    Time frame: Baseline, 7 to 12 weeks following the last injection

    BCVA is measured in the study eye following each injection of OZURDEX® using a special 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 improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.

  2. Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye

    Time frame: Baseline, Up to 12 Months

    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.

  3. Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye

    Time frame: Baseline, Up to 12 Months

    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.

  4. Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection

    Time frame: Baseline, 7 to 12 weeks following the last injection

    OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.

  5. Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Up to 12 Months

    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.

  6. Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Up to 12 Months

    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2012
Registry last updated
May 27, 2013

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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