At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 956 enrolled
Drug / intervention
fluocinolone acetonide +2 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.
A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema
In Brief
A Phase 3 clinical trial evaluating fluocinolone acetonide, Fluocinolone Acetonide, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 956 participants across 1 site.
Detailed Summary
This study will evaluate the 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
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2006
Enrollment StartSep 2007
Primary CompletionDec 2009
Study CompletionDec 2010
TodayJul 2026
First PostedJun 27, 2006
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.0 years ago
Interventions
fluocinolone acetonidedrug
0.5 mg fluocinolone acetonide intravitreal insert
Fluocinolone Acetonidedrug
0.2 mg fluocinolone acetonide intravitreal insert
Standard of care laser photocoagulationprocedure
Laser photocoagulation