Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema - Tabular View

Tracking Information
First Received Date ^ICMJE	June 26, 2006
Last Updated Date	January 2, 2008
Start Date ^ICMJE	September 2007
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 2, 2008)	Visual Acuity [ 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 NCT00344968 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	Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Official Title ^ICMJE
Brief Summary	This study will evaluate the 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, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetic Macular Edema
Intervention ^ICMJE	Drug: fluocinolone acetonide Drug: Fluocinolone Acetonide Procedure: Standard of care laser photocoagulation
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	900
Completion Date
Estimated Primary Completion Date	December 2009 (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 19-68 letters Retinal thickness > 250 micron 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 6 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	NCT00344968
Responsible Party	Director, Scientific Affairs, Alimera Sciences, Inc.
Study ID Numbers ^ICMJE	C-01-05-001
Study Sponsor ^ICMJE	Alimera Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Alimera Sciences
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP