CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Dexamethasone intravitreal implant +1 moredrug
Likely dose
Dexamethasone intravitreal implant 0.7mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04619303
NCT04619303Phase 4Completed

A Randomized Clinical Trial of Intravitreal dexamethasOne Versus Bevacizumab in Aboriginal and Torres Strait Islander patientS With Diabetic Macular Oedema (The OASIS Study)

Lions Eye Institute, Perth, Western Australia·interventional·Posted Nov 6, 2020·Updated Nov 9, 2020

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 6, 2020
Enrollment StartFeb 7, 2017
Primary CompletionFeb 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.7 years ago

Interventions

Dexamethasone intravitreal implantdrug

Intravitreal injection of 0.7mg dexamethasone implant

Bevacizumab Injectable Productdrug

Invtravitreal injection of 1.25mg/0.05mL bevacizumab