At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
Dexamethasonedrug
Likely dose
Dexamethasone 700 µgfrom 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.
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating Dexamethasone for Diabetic Macular Edema and Vitrectomy. Completed, enrolled 56 participants across 2 sites in 2 countries.
Detailed Summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema, Vitrectomy
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJan 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedNov 27, 2008
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.6 years ago
Interventions
Dexamethasonedrug
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.