At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
dexamethasone intravitreal implant +1 moredrug
Likely dose
dexamethasone intravitreal implant 0.7 mgfrom 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.
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
In Brief
A Phase 2 clinical trial evaluating dexamethasone intravitreal implant and intravitreal bevacizumab for Diabetic Macular Edema and 2 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
CountriesUnited States
CollaboratorsAllergan
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionFeb 2014
Study CompletionMar 2015
TodayJul 2026
First PostedApr 5, 2012
Enrollment StartApr 1, 2012
Primary CompletionFeb 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.2 years ago
Interventions
dexamethasone intravitreal implantdrug
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
intravitreal bevacizumabdrug
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.