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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00490815
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Fluocinolone Acetonide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
Study Start Date : August 2007
Primary Completion Date : September 2009
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
Experimental: 2 Drug: Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert


Outcome Measures

Primary Outcome Measures :
  1. Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor [ Time Frame: over 36 months ]
    This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.


Secondary Outcome Measures :
  1. Retinal Thickness [ Time Frame: over 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490815


Locations
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Alimera Sciences
More Information

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00490815     History of Changes
Other Study ID Numbers: C-01-06-002
First Posted: June 25, 2007    Key Record Dates
Results First Posted: February 13, 2014
Last Update Posted: February 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs