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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00344968
First received: June 26, 2006
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  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 3

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:

MedlinePlus related topics: Edema
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 June 18, 2013