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Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304706
First Posted: February 25, 2011
Last Update Posted: May 4, 2015
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.
Information provided by (Responsible Party):
Alimera Sciences
  Purpose
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.


Enrollment: 120
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
  2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
  3. Ability and willingness to comply with the treatment and follow up procedures.
  4. Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Exclusion Criteria:

  1. Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
  2. Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
  3. Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration)
  4. Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus)
  5. Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
  6. History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
  7. History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
  8. Any lens opacity which significantly impairs vision, in the opinion of the investigator.
  9. Peripheral retinal detachment in prospective area of insertion
  10. Participation in another clinical trial within 12 weeks before the screening visit or during the study
  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): NCT01304706


Locations
United States, Georgia
Alpharetta, Georgia, United States
Sponsors and Collaborators
Alimera Sciences
  More Information

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT01304706     History of Changes
Other Study ID Numbers: C-01-11-008
First Submitted: February 24, 2011
First Posted: February 25, 2011
Results First Submitted: April 17, 2015
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015

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