Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT01304706
First received: February 24, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema who have previously received either dose of the fluocinolone insert in the FAME studies.


Condition Intervention Phase
Diabetic Macular Edema
Drug: Fluocinolone Acetonide
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alimera Sciences:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2011
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluocinolone Acetonide Drug: Fluocinolone Acetonide
0.2 μg/day

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FAME study subjects
  • In the judgment of the Investigator, the subject will benefit from retreatment with ILUVIEN.

Exclusion Criteria:

  • Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
  • Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
  • History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
  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: NCT01304706

Locations
United States, Kentucky
University of Kentucky Department of Ophthalmology
Lexington, Kentucky, United States
Sponsors and Collaborators
Alimera Sciences
  More Information

No publications provided

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT01304706     History of Changes
Other Study ID Numbers: C-01-11-008
Study First Received: February 24, 2011
Last Updated: November 20, 2013
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 July 26, 2014