Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study
Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study
1 other identifier
observational
202
1 country
23
Brief Summary
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 8, 2016
CompletedStudy Start
First participant enrolled
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2018
CompletedJanuary 23, 2019
January 1, 2019
2.5 years
March 24, 2016
January 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Mean change in Best Corrected Visual Acuity (BCVA) from baseline
Baseline, Month 12
Mean change in Central Retinal Thickness (CRT) from baseline
Baseline, Month 12
Secondary Outcomes (13)
Percentage of patients with a BCVA improvement of 15 letters or more
Baseline, Month 12
Percentage of patients with a BCVA improvement of 10 letters or more
Baseline, Month 12
BCVA average mean from baseline in area under the curve (AUC) analysis
Baseline, Month 12
Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase
12 Months
Mean BCVA at each injection number
12 Months
- +8 more secondary outcomes
Study Arms (1)
Ozurdex® (dexamethasone intravitreal implant)
Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.
Interventions
Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.
Eligibility Criteria
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.
You may qualify if:
- Pseudophakic or phakic and scheduled for a cataract operation
- Macular oedema due to DME
You may not qualify if:
- Previous Ozurdex® treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (23)
Retina and Macula Specialists,Hurstville
Hurtsville, New South Wales, 2220, Australia
Retina Associates
Liverpool, New South Wales, 2170, Australia
Retina and Macula Specialists, Miranda
Miranda, New South Wales, 2228, Australia
Eye Doctors Mona Vale
Mona Vale, New South Wales, 2103, Australia
Marsden Eye Clinic
Parramatta, New South Wales, 2150, Australia
Retina & Vitreous Centre Strathfield
Strathfield, New South Wales, 2135, Australia
Strathfield Retina
Strathfield, New South Wales, 2135, Australia
Retina & Vitreous Centre City
Sydney, New South Wales, 2000, Australia
Sydney Eye and Retina Clinic
Sydney, New South Wales, 2000, Australia
Sydney Eye Hospital/Macular Diseases Centre
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Terrace Eye Centre
Brisbane, Queensland, 4000, Australia
Caboolture Eye Surgery
Caboolture, Queensland, 4510, Australia
Peninsula Eye Hospital
Redcliffe, Queensland, 4020, Australia
The Qld Eye Institute
South Brisbane, Queensland, 4101, Australia
Adelaide Eye & Retina Centre
Adelaide, South Australia, 5000, Australia
Department of Opthalmology, Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Hobart Eye Surgeons
Hobart, Tasmania, 5000, Australia
Tasmanian Eye Institute
Launceston, Tasmania, 7249, Australia
Essendon Retina
Essendon, Victoria, 3040, Australia
Victoria Parade Eye Consultants
Fitzroy, Victoria, 3065, Australia
Vision Eye Institute
Footscry, Victoria, 3011, Australia
Lions Eye Institute
Nedlands, Western Australia, 6009, Australia
Related Publications (2)
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.
PMID: 37541745DERIVEDFraser-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.
PMID: 34433549DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. George Labib
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 8, 2016
Study Start
April 29, 2016
Primary Completion
October 22, 2018
Study Completion
October 22, 2018
Last Updated
January 23, 2019
Record last verified: 2019-01