Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

NCT01304706 | Completed Phase 3 Results

• 1 other identifier: C-01-11-008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.

  12 months

Study Arms (1)

Fluocinolone Acetonide

EXPERIMENTAL

Drug: Fluocinolone Acetonide

Interventions

Fluocinolone Acetonide DRUG

0.2 μg/day

Fluocinolone Acetonide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alimera Sciences: lead

Study Sites (1)

Unknown Facility

Alpharetta, Georgia, United States

Location

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kathleen Billman, Senior Director, Scientific Affairs
• Organization: Alimera Sciences, Inc.

kathleen.billman@alimerasciences.com

678-527-1302

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2013
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04

Locations

US (1)