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Diabetic Macular OedemaNCT02731911

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

An observational study of Diabetic Macular Oedema, run by Allergan at 23 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Oedema
What is being tested?
dexamethasone intravitreal implant
How many people
202 participants
Where
23 sitesAustralia
Study dates
29 Apr 2016to 22 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Previous Ozurdex® treatment

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Australia23 sites

  • Adelaide Eye & Retina Centre

    Adelaide, South Australia, 5000

  • Department of Opthalmology, Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Terrace Eye Centre

    Brisbane, Queensland, 4000

  • Caboolture Eye Surgery

    Caboolture, Queensland, 4510

  • Essendon Retina

    Essendon, Victoria, 3040

  • Victoria Parade Eye Consultants

    Fitzroy, Victoria, 3065

  • Vision Eye Institute

    Footscry, Victoria, 3011

  • Hobart Eye Surgeons

    Hobart, Tasmania, 5000

  • Retina and Macula Specialists,Hurstville

    Hurtsville, New South Wales, 2220

  • Tasmanian Eye Institute

    Launceston, Tasmania, 7249

  • Retina Associates

    Liverpool, New South Wales, 2170

  • Retina and Macula Specialists, Miranda

    Miranda, New South Wales, 2228

  • Eye Doctors Mona Vale

    Mona Vale, New South Wales, 2103

  • Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Marsden Eye Clinic

    Parramatta, New South Wales, 2150

  • Peninsula Eye Hospital

    Redcliffe, Queensland, 4020

  • The Qld Eye Institute

    South Brisbane, Queensland, 4101

  • Retina & Vitreous Centre Strathfield

    Strathfield, New South Wales, 2135

  • Strathfield Retina

    Strathfield, New South Wales, 2135

  • Retina & Vitreous Centre City

    Sydney, New South Wales, 2000

  • Sydney Eye and Retina Clinic

    Sydney, New South Wales, 2000

  • Sydney Eye Hospital/Macular Diseases Centre

    Sydney, New South Wales, 2000

  • Sydney West Retina

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: 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.

Being tested
dexamethasone intravitreal implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexamethasone intravitreal implantDrug

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

Study groups in NCT02731911
Study groupRoleWhat they receive
Ozurdex® (dexamethasone intravitreal implant)Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.
Receives: Drug: dexamethasone intravitreal implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Month 12

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

    Measured: Baseline, Month 12

Secondary outcomes (13)

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

    Measured: Baseline, Month 12

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

    Measured: Baseline, Month 12

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

    Measured: Baseline, Month 12

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

    Measured: 12 Months

  5. Mean BCVA at each injection number

    Measured: 12 Months

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

    Measured: Baseline, Month 12

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

    Measured: Baseline, 12 Months

  8. Percentage of patients with BCVA improvement

    Measured: Baseline, Month 12

  9. Percentage of BCVA losers

    Measured: Baseline, Month 12

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

    Measured: Month 12

  11. Mean number of Ozurdex injections

    Measured: 12 Months

  12. Mean interval between Ozurdex® injections

    Measured: 12 Months

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

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2016 (estimated)
  2. Study start29 Apr 2016
  3. Primary completion22 Oct 2018
  4. Study completion22 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02731911
Sponsor's protocol ID
CMO-AP-EYE-0438
Status last verified
Jan 2019
First submitted
24 Mar 2016
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mitchell P, Arnold J, Fraser-Bell S, Kang HK, Chang AA, Tainton J, Simonyi S. Dexamethasone intravitreal implant in diabetic macular oedema refractory to anti-vascular endothelial growth factors: the AUSSIEDEX study. BMJ Open Ophthalmol. 2023 Aug;8(1):e001224. doi: 10.1136/bmjophth-2022-001224.

    PubMed 37541745

  • Fraser-Bell S, Kang HK, Mitchell P, Arnold JJ, Tainton J, Simonyi S. Dexamethasone intravitreal implant in treatment-naive diabetic macular oedema: findings from the prospective, multicentre, AUSSIEDEX study. Br J Ophthalmol. 2023 Jan;107(1):72-78. doi: 10.1136/bjophthalmol-2021-319070. Epub 2021 Aug 25.

    PubMed 34433549

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Oedema, run by Allergan at 23 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in Best Corrected Visual Acuity (BCVA) from baseline (time frame: Baseline, Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02731911, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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