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

Allergan23 sites in 1 country202 target enrollmentApril 29, 2016

Overview

Phase: Not Applicable
Intervention: dexamethasone intravitreal implant
Conditions: Diabetic Macular Oedema
Sponsor: Allergan
Enrollment: 202
Locations: 23
Primary Endpoint: Mean change in Central Retinal Thickness (CRT) from baseline
Status: Completed
Last Updated: 7 years ago

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

Registry

clinicaltrials.gov

Start Date

April 29, 2016

End Date

October 22, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

Patients who received Ozurdex® in the treatment of Diabetic Macular Oedema per local standard of care in clinical practice.

Intervention: dexamethasone intravitreal implant

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

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)