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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00490815
First received: June 21, 2007
Last updated: January 17, 2014
Last verified: January 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Enrollment: 37
Study Start Date: August 2007
Study Completion Date: April 2011
Primary Completion Date: September 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00490815     History of Changes
Other Study ID Numbers: C-01-06-002
Study First Received: June 21, 2007
Results First Received: September 27, 2013
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014