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

Sponsored by:	Alimera Sciences
Information provided by:	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

MedlinePlus related topics: Edema

Drug Information available for: Fluocinolone Fluocinolone acetonide

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Criteria

Inclusion Criteria:

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

Responsible Party:	Alimera Sciences, Inc. ( Director, Scientific Affairs )
Study ID Numbers:	C-01-05-001
Study First Received:	June 26, 2006
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00344968
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Fluocinolone Acetonide
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

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

Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009