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Completed

NCT Number: NCT01304706

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

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

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Key information

Conditions

Diabetic Macular Edema

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alpharetta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
  • In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
  • Ability and willingness to comply with the treatment and follow up procedures.
  • 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

  • Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
  • Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
  • 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)
  • 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)
  • Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
  • History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
  • History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
  • Any lens opacity which significantly impairs vision, in the opinion of the investigator.
  • Peripheral retinal detachment in prospective area of insertion
  • Participation in another clinical trial within 12 weeks before the screening visit or during the study

Treatment and study plan

Fluocinolone Acetonide

Drug

0.2 μg/day

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alimera Sciences

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
First posted
Feb 25, 2011
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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