Clinical trial NCT02731911: Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study
Official title: Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Oedema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous Ozurdex® treatment

Primary outcomes:
measure: Mean change in Best Corrected Visual Acuity (BCVA) from baseline
timeFrame: Baseline, Month 12
measure: Mean change in Central Retinal Thickness (CRT) from baseline
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percentage of patients with a BCVA improvement of 15 letters or more
timeFrame: Baseline, Month 12
measure: Percentage of patients with a BCVA improvement of 10 letters or more
timeFrame: Baseline, Month 12
measure: BCVA average mean from baseline in area under the curve (AUC) analysis
timeFrame: Baseline, Month 12
measure: Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase
timeFrame: 12 Months
measure: Mean BCVA at each injection number
timeFrame: 12 Months
measure: Mean change from baseline in BCVA at each injection number
timeFrame: Baseline, Month 12
measure: Mean change in BCVA across all the study injection numbers
timeFrame: Baseline, 12 Months
measure: Percentage of patients with BCVA improvement
timeFrame: Baseline, Month 12
measure: Percentage of BCVA losers
timeFrame: Baseline, Month 12
measure: Percentage of patients improving to 20/40 or better
timeFrame: Month 12
measure: Mean number of Ozurdex injections
timeFrame: 12 Months
measure: Mean interval between Ozurdex® injections
timeFrame: 12 Months
measure: Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Hurtsville
country: Australia
facility: Retina and Macula Specialists,Hurstville
state: New South Wales
city: Liverpool
country: Australia
facility: Retina Associates
state: New South Wales
city: Miranda
country: Australia
facility: Retina and Macula Specialists, Miranda
state: New South Wales
city: Mona Vale
country: Australia
facility: Eye Doctors Mona Vale
state: New South Wales
city: Parramatta
country: Australia
facility: Marsden Eye Clinic
state: New South Wales
city: Strathfield
country: Australia
facility: Retina & Vitreous Centre Strathfield
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina
state: New South Wales
city: Sydney
country: Australia
facility: Retina & Vitreous Centre City
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye and Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital/Macular Diseases Centre
state: New South Wales
city: Westmead
country: Australia
facility: Sydney West Retina
state: New South Wales
city: Brisbane
country: Australia
facility: Terrace Eye Centre
state: Queensland
city: Caboolture
country: Australia
facility: Caboolture Eye Surgery
state: Queensland
city: Redcliffe
country: Australia
facility: Peninsula Eye Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: The Qld Eye Institute
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Eye & Retina Centre
state: South Australia
city: Adelaide
country: Australia
facility: Department of Opthalmology, Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Hobart Eye Surgeons
state: Tasmania
city: Launceston
country: Australia
facility: Tasmanian Eye Institute
state: Tasmania
city: Essendon
country: Australia
facility: Essendon Retina
state: Victoria
city: Fitzroy
country: Australia
facility: Victoria Parade Eye Consultants
state: Victoria
city: Footscry
country: Australia
facility: Vision Eye Institute
state: Victoria
city: Nedlands
country: Australia
facility: Lions Eye Institute
state: Western Australia
Study officials:
affiliation: Allergan
name: Dr. George Labib
role: STUDY_DIRECTOR
References:
citation: 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.