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

Diabetic Macular Oedema Clinical Trial

Official title:

Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731911
• Other study ID #: CMO-AP-EYE-0438
• Status: Completed
• Start date: April 29, 2016
• Est. completion date: October 22, 2018

Study information

• Verified date: January 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pseudophakic or phakic and scheduled for a cataract operation

• Macular oedema due to DME

Exclusion Criteria:

• Previous Ozurdex® treatment

Related Conditions & MeSH terms

• Diabetic Macular Oedema
• Edema
• Macular Edema

Intervention

Drug:
• dexamethasone intravitreal implant
Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.

Locations

Country	Name	City	State
Australia	Adelaide Eye & Retina Centre	Adelaide	South Australia
Australia	Department of Opthalmology, Royal Adelaide Hospital	Adelaide	South Australia
Australia	Terrace Eye Centre	Brisbane	Queensland
Australia	Caboolture Eye Surgery	Caboolture	Queensland
Australia	Essendon Retina	Essendon	Victoria
Australia	Victoria Parade Eye Consultants	Fitzroy	Victoria
Australia	Vision Eye Institute	Footscry	Victoria
Australia	Hobart Eye Surgeons	Hobart	Tasmania
Australia	Retina and Macula Specialists,Hurstville	Hurtsville	New South Wales
Australia	Tasmanian Eye Institute	Launceston	Tasmania
Australia	Retina Associates	Liverpool	New South Wales
Australia	Retina and Macula Specialists, Miranda	Miranda	New South Wales
Australia	Eye Doctors Mona Vale	Mona Vale	New South Wales
Australia	Lions Eye Institute	Nedlands	Western Australia
Australia	Marsden Eye Clinic	Parramatta	New South Wales
Australia	Peninsula Eye Hospital	Redcliffe	Queensland
Australia	The Qld Eye Institute	South Brisbane	Queensland
Australia	Retina & Vitreous Centre Strathfield	Strathfield	New South Wales
Australia	Strathfield Retina	Strathfield	New South Wales
Australia	Retina & Vitreous Centre City	Sydney	New South Wales
Australia	Sydney Eye and Retina Clinic	Sydney	New South Wales
Australia	Sydney Eye Hospital/Macular Diseases Centre	Sydney	New South Wales
Australia	Sydney West Retina	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Best Corrected Visual Acuity (BCVA) from baseline		Baseline, Month 12
Primary	Mean change in Central Retinal Thickness (CRT) from baseline		Baseline, Month 12
Secondary	Percentage of patients with a BCVA improvement of 15 letters or more		Baseline, Month 12
Secondary	Percentage of patients with a BCVA improvement of 10 letters or more		Baseline, Month 12
Secondary	BCVA average mean from baseline in area under the curve (AUC) analysis		Baseline, Month 12
Secondary	Number of Intraocular Pressure (IOP)-lowering treatments used to control IOP increase		12 Months
Secondary	Mean BCVA at each injection number		12 Months
Secondary	Mean change from baseline in BCVA at each injection number		Baseline, Month 12
Secondary	Mean change in BCVA across all the study injection numbers		Baseline, 12 Months
Secondary	Percentage of patients with BCVA improvement		Baseline, Month 12
Secondary	Percentage of BCVA losers		Baseline, Month 12
Secondary	Percentage of patients improving to 20/40 or better		Month 12
Secondary	Mean number of Ozurdex injections		12 Months
Secondary	Mean interval between Ozurdex® injections		12 Months
Secondary	Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number		Baseline, Month 12