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

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ClinicalTrials.gov Identifier: NCT02731911
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.

Condition or disease Intervention/treatment
Diabetic Macular Oedema Drug: dexamethasone intravitreal implant

Study Design
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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : October 22, 2018
Actual Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ozurdex® (dexamethasone intravitreal implant)
Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.
 Drug: dexamethasone intravitreal implant
Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in Best Corrected Visual Acuity (BCVA) from baseline [ Time Frame: Baseline, Month 12 ]
  2. Mean change in Central Retinal Thickness (CRT) from baseline [ Time Frame: Baseline, Month 12 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Pseudophakic or phakic and scheduled for a cataract operation
  • Macular oedema due to DME

Exclusion Criteria:

  • Previous Ozurdex® treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731911


Locations
Show Show 23 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Dr. George Labib Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02731911    
Other Study ID Numbers: CMO-AP-EYE-0438
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents