NCT02731911CompletedNot Applicable
Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 202
- Locations
- 23
- Primary Endpoint
- Mean change in Central Retinal Thickness (CRT) from baseline
Study Overview
Brief Summary
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pseudophakic or phakic and scheduled for a cataract operation
- •Macular oedema due to DME
Exclusion Criteria
- •Previous Ozurdex® treatment
Arms & Interventions
Ozurdex® (dexamethasone intravitreal implant)
Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.
Intervention: dexamethasone intravitreal implant (Drug)
Outcomes
Primary Outcomes
Mean change in Central Retinal Thickness (CRT) from baseline
Time Frame: Baseline, Month 12
Mean change in Best Corrected Visual Acuity (BCVA) from baseline
Time Frame: Baseline, Month 12
Secondary Outcomes
- Mean number of Ozurdex injections(12 Months)
- Mean interval between Ozurdex® injections(12 Months)
- Percentage of BCVA losers(Baseline, Month 12)
- Percentage of patients improving to 20/40 or better(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 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)
Investigators
Study Sites (23)
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