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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02731911




Registration number
NCT02731911
Ethics application status
Date submitted
24/03/2016
Date registered
8/04/2016
Date last updated
23/01/2019

Titles & IDs
Public title
Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study
Scientific title
Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study
Secondary ID [1] 0 0
CMO-AP-EYE-0438
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - dexamethasone intravitreal implant

Ozurdex® (dexamethasone intravitreal implant) - Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.


Treatment: Drugs: dexamethasone intravitreal implant
Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in Best Corrected Visual Acuity (BCVA) from baseline
Timepoint [1] 0 0
Baseline, Month 12
Primary outcome [2] 0 0
Mean change in Central Retinal Thickness (CRT) from baseline
Timepoint [2] 0 0
Baseline, Month 12
Secondary outcome [1] 0 0
Percentage of patients with a BCVA improvement of 15 letters or more
Timepoint [1] 0 0
Baseline, Month 12
Secondary outcome [2] 0 0
Percentage of patients with a BCVA improvement of 10 letters or more
Timepoint [2] 0 0
Baseline, Month 12
Secondary outcome [3] 0 0
BCVA average mean from baseline in area under the curve (AUC) analysis
Timepoint [3] 0 0
Baseline, Month 12
Secondary outcome [4] 0 0
Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
Mean BCVA at each injection number
Timepoint [5] 0 0
12 Months
Secondary outcome [6] 0 0
Mean change from baseline in BCVA at each injection number
Timepoint [6] 0 0
Baseline, Month 12
Secondary outcome [7] 0 0
Mean change in BCVA across all the study injection numbers
Timepoint [7] 0 0
Baseline, 12 Months
Secondary outcome [8] 0 0
Percentage of patients with BCVA improvement
Timepoint [8] 0 0
Baseline, Month 12
Secondary outcome [9] 0 0
Percentage of BCVA losers
Timepoint [9] 0 0
Baseline, Month 12
Secondary outcome [10] 0 0
Percentage of patients improving to 20/40 or better
Timepoint [10] 0 0
Month 12
Secondary outcome [11] 0 0
Mean number of Ozurdex injections
Timepoint [11] 0 0
12 Months
Secondary outcome [12] 0 0
Mean interval between Ozurdex® injections
Timepoint [12] 0 0
12 Months
Secondary outcome [13] 0 0
Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number
Timepoint [13] 0 0
Baseline, Month 12

Eligibility
Key inclusion criteria
* Pseudophakic or phakic and scheduled for a cataract operation
* Macular oedema due to DME
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous Ozurdex® treatment

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2018
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Retina and Macula Specialists,Hurstville - Hurtsville
Recruitment hospital [2] 0 0
Retina Associates - Liverpool
Recruitment hospital [3] 0 0
Retina and Macula Specialists, Miranda - Miranda
Recruitment hospital [4] 0 0
Eye Doctors Mona Vale - Mona Vale
Recruitment hospital [5] 0 0
Marsden Eye Clinic - Parramatta
Recruitment hospital [6] 0 0
Retina & Vitreous Centre Strathfield - Strathfield
Recruitment hospital [7] 0 0
Strathfield Retina - Strathfield
Recruitment hospital [8] 0 0
Retina & Vitreous Centre City - Sydney
Recruitment hospital [9] 0 0
Sydney Eye and Retina Clinic - Sydney
Recruitment hospital [10] 0 0
Sydney Eye Hospital/Macular Diseases Centre - Sydney
Recruitment hospital [11] 0 0
Sydney West Retina - Westmead
Recruitment hospital [12] 0 0
Terrace Eye Centre - Brisbane
Recruitment hospital [13] 0 0
Caboolture Eye Surgery - Caboolture
Recruitment hospital [14] 0 0
Peninsula Eye Hospital - Redcliffe
Recruitment hospital [15] 0 0
The Qld Eye Institute - South Brisbane
Recruitment hospital [16] 0 0
Adelaide Eye & Retina Centre - Adelaide
Recruitment hospital [17] 0 0
Department of Opthalmology, Royal Adelaide Hospital - Adelaide
Recruitment hospital [18] 0 0
Hobart Eye Surgeons - Hobart
Recruitment hospital [19] 0 0
Tasmanian Eye Institute - Launceston
Recruitment hospital [20] 0 0
Essendon Retina - Essendon
Recruitment hospital [21] 0 0
Victoria Parade Eye Consultants - Fitzroy
Recruitment hospital [22] 0 0
Vision Eye Institute - Footscry
Recruitment hospital [23] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2220 - Hurtsville
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
2103 - Mona Vale
Recruitment postcode(s) [5] 0 0
2150 - Parramatta
Recruitment postcode(s) [6] 0 0
2135 - Strathfield
Recruitment postcode(s) [7] 0 0
2000 - Sydney
Recruitment postcode(s) [8] 0 0
2145 - Westmead
Recruitment postcode(s) [9] 0 0
4000 - Brisbane
Recruitment postcode(s) [10] 0 0
4510 - Caboolture
Recruitment postcode(s) [11] 0 0
4020 - Redcliffe
Recruitment postcode(s) [12] 0 0
4101 - South Brisbane
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
5000 - Hobart
Recruitment postcode(s) [15] 0 0
7249 - Launceston
Recruitment postcode(s) [16] 0 0
3040 - Essendon
Recruitment postcode(s) [17] 0 0
3065 - Fitzroy
Recruitment postcode(s) [18] 0 0
3011 - Footscry
Recruitment postcode(s) [19] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.
Trial website
https://clinicaltrials.gov/study/NCT02731911
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dr. George Labib
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02731911