Working… Menu
Trial record 2 of 2 for:    fluocinolone AND fame

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

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. Identifier: NCT01304706
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Information provided by (Responsible Party):
Alimera Sciences

Brief Summary:
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2011
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Fluocinolone Acetonide Drug: Fluocinolone Acetonide
0.2 μg/day

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01304706

Layout table for location information
United States, Georgia
Alpharetta, Georgia, United States
Sponsors and Collaborators
Alimera Sciences
Layout table for additonal information
Responsible Party: Alimera Sciences Identifier: NCT01304706    
Other Study ID Numbers: C-01-11-008
First Posted: February 25, 2011    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Fluocinolone Acetonide
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs