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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alimera Sciences

ClinicalTrials.gov Identifier:

NCT00344968

First received: June 26, 2006

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2006
Last Updated Date	January 31, 2012
Start Date ^ICMJE	September 2007
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	Not Provided
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	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Diabetic Macular Edema
Intervention ^ICMJE	Drug: fluocinolone acetonide 0.5 mg fluocinolone acetonide intravitreal insert Drug: Fluocinolone Acetonide 0.2 mg fluocinolone acetonide intravitreal insert Procedure: Standard of care laser photocoagulation Laser photocoagulation
Study Arm (s)	Experimental: 1 Intervention: Drug: fluocinolone acetonide Experimental: 2 Intervention: Drug: Fluocinolone Acetonide Sham Comparator: 3 Intervention: Procedure: Standard of care laser photocoagulation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	900
Completion Date	December 2010
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 Number ^ICMJE	NCT00344968
Other Study ID Numbers ^ICMJE	C-01-05-001
Has Data Monitoring Committee	Not Provided
Responsible Party	Alimera Sciences
Study Sponsor ^ICMJE	Alimera Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alimera Sciences
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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