Diabetic Macular Oedema
Conditions
Brief summary
This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.
Interventions
DRUGdexamethasone intravitreal implant
Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pseudophakic or phakic and scheduled for a cataract operation * Macular oedema due to DME
Exclusion criteria
* Previous Ozurdex® treatment
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 a BCVA improvement of 15 letters or more | 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 |
| Percentage of patients with BCVA improvement | Baseline, Month 12 |
| Percentage of patients with a BCVA improvement of 10 letters or more | Baseline, Month 12 |
Countries
Australia
Outcome results
None listed