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

January 21, 2019 updated by: Allergan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Hurtsville, New South Wales, Australia, 2220
        • Retina and Macula Specialists,Hurstville
      • Liverpool, New South Wales, Australia, 2170
        • Retina Associates
      • Miranda, New South Wales, Australia, 2228
        • Retina and Macula Specialists, Miranda
      • Mona Vale, New South Wales, Australia, 2103
        • Eye Doctors Mona Vale
      • Parramatta, New South Wales, Australia, 2150
        • Marsden Eye Clinic
      • Strathfield, New South Wales, Australia, 2135
        • Retina & Vitreous Centre Strathfield
      • Strathfield, New South Wales, Australia, 2135
        • Strathfield Retina
      • Sydney, New South Wales, Australia, 2000
        • Retina & Vitreous Centre City
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye and Retina Clinic
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital/Macular Diseases Centre
      • Westmead, New South Wales, Australia, 2145
        • Sydney West Retina
    • Queensland
      • Brisbane, Queensland, Australia, 4000
        • Terrace Eye Centre
      • Caboolture, Queensland, Australia, 4510
        • Caboolture Eye Surgery
      • Redcliffe, Queensland, Australia, 4020
        • Peninsula Eye Hospital
      • South Brisbane, Queensland, Australia, 4101
        • The Qld Eye Institute
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Adelaide Eye & Retina Centre
      • Adelaide, South Australia, Australia, 5000
        • Department of Opthalmology, Royal Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 5000
        • Hobart Eye Surgeons
      • Launceston, Tasmania, Australia, 7249
        • Tasmanian Eye Institute
    • Victoria
      • Essendon, Victoria, Australia, 3040
        • Essendon Retina
      • Fitzroy, Victoria, Australia, 3065
        • Victoria Parade Eye Consultants
      • Footscry, Victoria, Australia, 3011
        • Vision Eye Institute
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Lions Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are pseudophakic, or phakic and scheduled for a cataract operation, and with a diagnosis of Diabetic Macular Oedema in one or both eyes who are to be treated with Ozurdex® at least once as determined by their physician.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous Ozurdex® treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ozurdex® (dexamethasone intravitreal implant)
Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.
Drug: dexamethasone intravitreal implant
Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in Best Corrected Visual Acuity (BCVA) from baseline
Time Frame: Baseline, Month 12
Baseline, Month 12
Mean change in Central Retinal Thickness (CRT) from baseline
Time Frame: Baseline, Month 12
Baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with a BCVA improvement of 15 letters or more
Time Frame: Baseline, Month 12
Baseline, Month 12
Percentage of patients with a BCVA improvement of 10 letters or more
Time Frame: Baseline, Month 12
Baseline, Month 12
BCVA average mean from baseline in area under the curve (AUC) analysis
Time Frame: Baseline, Month 12
Baseline, Month 12
Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase
Time Frame: 12 Months
12 Months
Mean BCVA at each injection number
Time Frame: 12 Months
12 Months
Mean change from baseline in BCVA at each injection number
Time Frame: Baseline, Month 12
Baseline, Month 12
Mean change in BCVA across all the study injection numbers
Time Frame: Baseline, 12 Months
Baseline, 12 Months
Percentage of patients with BCVA improvement
Time Frame: Baseline, Month 12
Baseline, Month 12
Percentage of BCVA losers
Time Frame: Baseline, Month 12
Baseline, Month 12
Percentage of patients improving to 20/40 or better
Time Frame: Month 12
Month 12
Mean number of Ozurdex injections
Time Frame: 12 Months
12 Months
Mean interval between Ozurdex® injections
Time Frame: 12 Months
12 Months
Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number
Time Frame: Baseline, Month 12
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Dr. George Labib, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2016

Primary Completion (ACTUAL)

October 22, 2018

Study Completion (ACTUAL)

October 22, 2018

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO-AP-EYE-0438

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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