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This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex® (dexamethasone intravitreal implant) | Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant | Drug | Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Best Corrected Visual Acuity (BCVA) from baseline | Baseline, Month 12 | |
| Mean change in Central Retinal Thickness (CRT) from baseline | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. George Labib | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina and Macula Specialists,Hurstville | Hurtsville | New South Wales | 2220 | Australia | ||
| Retina Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37541745 | Derived | Mitchell P, Arnold J, Fraser-Bell S, Kang HK, Chang AA, Tainton J, Simonyi S. Dexamethasone intravitreal implant in diabetic macular oedema refractory to anti-vascular endothelial growth factors: the AUSSIEDEX study. BMJ Open Ophthalmol. 2023 Aug;8(1):e001224. doi: 10.1136/bmjophth-2022-001224. | |
| 34433549 | Derived |
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| BCVA average mean from baseline in area under the curve (AUC) analysis |
| 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 |
| Mean change in BCVA across all the study injection numbers | Baseline, 12 Months |
| Percentage of patients with BCVA improvement | Baseline, Month 12 |
| Percentage of BCVA losers | Baseline, Month 12 |
| Percentage of patients improving to 20/40 or better | Month 12 |
| Mean number of Ozurdex injections | 12 Months |
| Mean interval between Ozurdex® injections | 12 Months |
| Change from baseline in central subfield retinal thickness by Optical Coherence Tomography (OCT) before each follow-up injection number | Baseline, Month 12 |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| Retina and Macula Specialists, Miranda | Miranda | New South Wales | 2228 | Australia |
| Eye Doctors Mona Vale | Mona Vale | New South Wales | 2103 | Australia |
| Marsden Eye Clinic | Parramatta | New South Wales | 2150 | Australia |
| Retina & Vitreous Centre Strathfield | Strathfield | New South Wales | 2135 | Australia |
| Strathfield Retina | Strathfield | New South Wales | 2135 | Australia |
| Retina & Vitreous Centre City | Sydney | New South Wales | 2000 | Australia |
| Sydney Eye and Retina Clinic | Sydney | New South Wales | 2000 | Australia |
| Sydney Eye Hospital/Macular Diseases Centre | Sydney | New South Wales | 2000 | Australia |
| Sydney West Retina | Westmead | New South Wales | 2145 | Australia |
| Terrace Eye Centre | Brisbane | Queensland | 4000 | Australia |
| Caboolture Eye Surgery | Caboolture | Queensland | 4510 | Australia |
| Peninsula Eye Hospital | Redcliffe | Queensland | 4020 | Australia |
| The Qld Eye Institute | South Brisbane | Queensland | 4101 | Australia |
| Adelaide Eye & Retina Centre | Adelaide | South Australia | 5000 | Australia |
| Department of Opthalmology, Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Hobart Eye Surgeons | Hobart | Tasmania | 5000 | Australia |
| Tasmanian Eye Institute | Launceston | Tasmania | 7249 | Australia |
| Essendon Retina | Essendon | Victoria | 3040 | Australia |
| Victoria Parade Eye Consultants | Fitzroy | Victoria | 3065 | Australia |
| Vision Eye Institute | Footscry | Victoria | 3011 | Australia |
| Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| 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. |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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