Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema - Tabular View

Tracking Information
First Received Date ^ICMJE	June 21, 2007
Last Updated Date	March 3, 2008
Start Date ^ICMJE	August 2007
Estimated Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 2, 2008)	Levels of fluocinolone acetonide in plasma and aqueous humor [ Time Frame: over 36 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00490815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 2, 2008)	Retinal Thickness [ Time Frame: over 36 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Official Title ^ICMJE
Brief Summary	This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Condition ^ICMJE	Diabetic Macular Edema
Intervention ^ICMJE	Drug: Fluocinolone Acetonide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	October 2010
Estimated Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age >= 18 years with diabetic macular edema Diagnosis of diabetes mellitus types 1 or 2 Best corrected visual acuity of ≥ 19 letters Retinal thickness > 250 microns by OCT Investigator is comfortable deferring macular laser treatment for 6 weeks Exclusion Criteria: Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months Any ocular surgery within the last 3 months Retinal laser treatment within the last 3 months History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy Any lens opacity which impairs visualization of the posterior pole
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00490815
Responsible Party	Director, Scientific Affairs, Alimera Sciences, Inc.
Study ID Numbers ^ICMJE	C-01-06-002
Study Sponsor ^ICMJE	Alimera Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Alimera Sciences
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP