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

This study is ongoing, but not recruiting participants.

First Received: June 21, 2007 Last Updated: March 3, 2008 History of Changes

Sponsor:	Alimera Sciences
Information provided by:	Alimera Sciences
ClinicalTrials.gov Identifier:	NCT00490815

Purpose

This study will evaluate the pharmacokinetics, 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	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study

Resource links provided by NLM:

Genetics Home Reference related topics: 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:

Levels of fluocinolone acetonide in plasma and aqueous humor [ 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:	30
Study Start Date:	August 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2008 (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

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490815

Locations

United States, Maryland
John Hopkins University
Baltimore, Maryland, United States

Sponsors and Collaborators

Alimera Sciences

More Information

No publications provided

Responsible Party:	Alimera Sciences, Inc. ( Director, Scientific Affairs )
Study ID Numbers:	C-01-06-002
Study First Received:	June 21, 2007
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00490815 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Fluocinolone Acetonide
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration

Glucocorticoids
Hormones
Pharmacologic Actions
Macular Edema
Signs and Symptoms
Therapeutic Uses
Retinal Diseases

ClinicalTrials.gov processed this record on November 27, 2009