Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study
- Registration Number
- NCT02731911
- Lead Sponsor
- Allergan
- Brief Summary
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- Pseudophakic or phakic and scheduled for a cataract operation
- Macular oedema due to DME
- Previous Ozurdex® treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ozurdex® (dexamethasone intravitreal implant) dexamethasone intravitreal implant Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.
- Primary Outcome Measures
Name Time Method Mean change in Central Retinal Thickness (CRT) from baseline Baseline, Month 12 Mean change in Best Corrected Visual Acuity (BCVA) from baseline Baseline, Month 12
- Secondary Outcome Measures
Name Time Method Mean number of Ozurdex injections 12 Months Percentage of BCVA losers 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 Mean change from baseline in BCVA at each injection number Baseline, Month 12 Percentage of patients improving to 20/40 or better Month 12 Mean interval between Ozurdex® injections 12 Months 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 Mean change in BCVA across all the study injection numbers Baseline, 12 Months Percentage of patients with BCVA improvement Baseline, Month 12 Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number Baseline, Month 12
Trial Locations
- Locations (23)
Retina and Macula Specialists,Hurstville
🇦🇺Hurtsville, New South Wales, 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
Marsden Eye Clinic
🇦🇺Parramatta, New South Wales, Australia
Retina & Vitreous Centre Strathfield
🇦🇺Strathfield, New South Wales, Australia
Strathfield Retina
🇦🇺Strathfield, New South Wales, Australia
Sydney West Retina
🇦🇺Westmead, New South Wales, Australia
Caboolture Eye Surgery
🇦🇺Caboolture, Queensland, Australia
Terrace Eye Centre
🇦🇺Brisbane, Queensland, Australia
Peninsula Eye Hospital
🇦🇺Redcliffe, Queensland, Australia
The Qld Eye Institute
🇦🇺South Brisbane, Queensland, Australia
Adelaide Eye & Retina Centre
🇦🇺Adelaide, South Australia, Australia
Department of Opthalmology, Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Hobart Eye Surgeons
🇦🇺Hobart, Tasmania, Australia
Tasmanian Eye Institute
🇦🇺Launceston, Tasmania, Australia
Essendon Retina
🇦🇺Essendon, Victoria, Australia
Vision Eye Institute
🇦🇺Footscry, Victoria, Australia
Retina & Vitreous Centre City
🇦🇺Sydney, New South Wales, Australia
Sydney Eye and Retina Clinic
🇦🇺Sydney, New South Wales, Australia
Victoria Parade Eye Consultants
🇦🇺Fitzroy, Victoria, Australia
Sydney Eye Hospital/Macular Diseases Centre
🇦🇺Sydney, New South Wales, Australia
Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia