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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02731911