At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 37 enrolled
Drug / intervention
Fluocinolone Acetonide +1 moredrug
Likely dose
Fluocinolone Acetonide 0.5 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.
An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
In Brief
A Phase 3 clinical trial evaluating Fluocinolone Acetonide for Diabetic Macular Edema. Completed, enrolled 37 participants across 1 site.
Detailed Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartAug 2007
Primary CompletionSep 2009
Study CompletionApr 2011
TodayJul 2026
First PostedJun 25, 2007
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2009
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.0 years ago
Interventions
Fluocinolone Acetonidedrug
0.5 mg fluocinolone acetonide intravitreal insert
Fluocinolone Acetonidedrug
0.2 mg fluocinolone acetonide intravitreal insert