At a glance
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A Randomized Clinical Trial of Intravitreal dexamethasOne Versus Bevacizumab in Aboriginal and Torres Strait Islander patientS With Diabetic Macular Oedema (The OASIS Study)
In Brief
A Phase 4 clinical trial evaluating Dexamethasone intravitreal implant and Bevacizumab Injectable Product for Diabetic Macular Edema and Diabetic Retinopathy. Completed, enrolled 59 participants across 13 sites.
Detailed Summary
DMO is the most common cause of visual loss in people with diabetes. Regular injections of bevacizumab (Avastin) given as frequently as every month remain the current standard of care for centre-involving DMO; however, this regimen is impractical for many Aboriginal patients. Using Ozurdex implants every 3-6 months could be as effective as the currently used Avastin injections. In order to address this real-world problem, this study seeks to investigate whether it is possible to safely use a long-acting steroid preparation such as the dexamethasone IVT implant (Ozurdex) to manage DMO in Aboriginal patients living in Western Australia.
Study Details
Timeline
Interventions
Intravitreal injection of 0.7mg dexamethasone implant
Invtravitreal injection of 1.25mg/0.05mL bevacizumab