Skip to main content
OpenTrials
Completed

NCT Number: NCT02731911

Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study

This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Macular Oedema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina and Macula Specialists,Hurstville, Hurtsville, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pseudophakic or phakic and scheduled for a cataract operation
  • Macular oedema due to DME

Exclusion criteria

  • Previous Ozurdex® treatment

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.

Primary outcomes

  1. Mean change in Best Corrected Visual Acuity (BCVA) from baseline

    Time frame: Baseline, Month 12

  2. Mean change in Central Retinal Thickness (CRT) from baseline

    Time frame: Baseline, Month 12

Secondary outcomes

  1. Percentage of patients with a BCVA improvement of 15 letters or more

    Time frame: Baseline, Month 12

  2. Percentage of patients with a BCVA improvement of 10 letters or more

    Time frame: Baseline, Month 12

  3. BCVA average mean from baseline in area under the curve (AUC) analysis

    Time frame: Baseline, Month 12

  4. Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase

    Time frame: 12 Months

  5. Mean BCVA at each injection number

    Time frame: 12 Months

  6. Mean change from baseline in BCVA at each injection number

    Time frame: Baseline, Month 12

  7. Mean change in BCVA across all the study injection numbers

    Time frame: Baseline, 12 Months

  8. Percentage of patients with BCVA improvement

    Time frame: Baseline, Month 12

  9. Percentage of BCVA losers

    Time frame: Baseline, Month 12

  10. Percentage of patients improving to 20/40 or better

    Time frame: Month 12

  11. Mean number of Ozurdex injections

    Time frame: 12 Months

  12. Mean interval between Ozurdex® injections

    Time frame: 12 Months

  13. Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number

    Time frame: Baseline, Month 12

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2016
Registry last updated
Jan 23, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.