- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304706
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
April 17, 2015 updated by: Alimera Sciences
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Alpharetta, Georgia, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluocinolone Acetonide
|
0.2 μg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
February 24, 2011
First Submitted That Met QC Criteria
February 24, 2011
First Posted (Estimate)
February 25, 2011
Study Record Updates
Last Update Posted (Estimate)
May 4, 2015
Last Update Submitted That Met QC Criteria
April 17, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-01-11-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Macular Edema
-
OcugenNot yet recruitingDiabetic Macular Edema | Center Involved Diabetic Macular Edema
-
California Retina ConsultantsRegeneron PharmaceuticalsCompletedDiabetic Macular Edema | Cystoid Macular EdemaUnited States
-
OculisICON plcRecruitingDiabetic Macular EdemaUnited States
-
Novartis PharmaceuticalsNot yet recruiting
-
Vista KlinikNot yet recruitingDiabetic Macular Edema
-
Chinese University of Hong KongRecruiting
-
Laboratorios Sophia S.A de C.V.RecruitingDiabetic Macular EdemaColombia, Mexico
-
Centre Hospitalier Universitaire DijonRecruiting
-
Uptown Eye SpecialistsNot yet recruitingDiabetic Macular Edema
-
Hospices Civils de LyonRecruiting
Clinical Trials on Fluocinolone Acetonide
-
Bausch & Lomb IncorporatedTerminatedNon-infectious Uveitis
-
Bausch & Lomb IncorporatedCompletedNoninfectious Posterior UveitisUnited States
-
Bausch & Lomb IncorporatedCompletedInflammation | UveitisUnited States
-
Bausch & Lomb IncorporatedCompletedDiabetic Macular EdemaChina, India
-
Bausch & Lomb IncorporatedCompletedUveitis, PosteriorUnited States
-
The Cleveland ClinicWithdrawn
-
Johns Hopkins UniversityAlimera Sciences; pSiVida LimitedCompletedAge Related Macular DegenerationUnited States
-
Duke UniversityBausch & Lomb IncorporatedCompleted
-
Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
-
Bausch & Lomb IncorporatedCompletedDiabetic Macular Edema