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

This study has been completed.

First Received on June 26, 2006. Last Updated on January 31, 2012 History of Changes

Sponsor:	Alimera Sciences
Information provided by (Responsible Party):	Alimera Sciences
ClinicalTrials.gov Identifier:	NCT00344968

Purpose

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: fluocinolone acetonide Drug: Fluocinolone Acetonide Procedure: Standard of care laser photocoagulation	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Fluocinolone acetonide Fluocinolone

U.S. FDA Resources

Further study details as provided by Alimera Sciences:

Primary Outcome Measures:

Visual Acuity [ Time Frame: over 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Retinal Thickness [ Time Frame: over 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	September 2007
Study Completion Date:	December 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: fluocinolone acetonide 0.5 mg fluocinolone acetonide intravitreal insert
Experimental: 2	Drug: Fluocinolone Acetonide 0.2 mg fluocinolone acetonide intravitreal insert
Sham Comparator: 3	Procedure: Standard of care laser photocoagulation Laser photocoagulation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344968

Locations

United States, Georgia

Atlanta, Georgia, United States

Sponsors and Collaborators

Alimera Sciences

More Information

No publications provided

Responsible Party:	Alimera Sciences
ClinicalTrials.gov Identifier:	NCT00344968 History of Changes
Other Study ID Numbers:	C-01-05-001
Study First Received:	June 26, 2006
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012