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Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema (FAME)

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ClinicalTrials.gov Identifier: NCT00344968
Recruitment Status : Completed
First Posted : June 27, 2006
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences

Tracking Information
First Submitted Date  ICMJE June 26, 2006
First Posted Date  ICMJE June 27, 2006
Results First Submitted Date  ICMJE September 27, 2013
Results First Posted Date  ICMJE May 7, 2014
Last Update Posted Date May 7, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2014)
Visual Acuity [ Time Frame: 36 months ]
The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2014)
Retinal Thickness [ Time Frame: 36 months ]
Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Official Title  ICMJE A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema
Brief Summary This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: fluocinolone acetonide
    0.5 mg fluocinolone acetonide intravitreal insert
  • Drug: Fluocinolone Acetonide
    0.2 mg fluocinolone acetonide intravitreal insert
  • Procedure: Standard of care laser photocoagulation
    Laser photocoagulation
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: fluocinolone acetonide
  • Experimental: 2
    Intervention: Drug: Fluocinolone Acetonide
  • Sham Comparator: 3
    Intervention: Procedure: Standard of care laser photocoagulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2014)
956
Original Enrollment  ICMJE
 (submitted: June 26, 2006)
900
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >= 18 years with diabetic macular edema
  • Diagnosis of diabetes mellitus types 1 or 2
  • Best corrected visual acuity of 19-68 letters
  • Retinal thickness > 250 micron by OCT
  • Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

  • Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents
  • Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
  • Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
  • Any ocular surgery within the last 3 months
  • Retinal laser treatment within the last 3 months
  • History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
  • Any lens opacity which impairs visualization of the posterior pole
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00344968
Other Study ID Numbers  ICMJE C-01-05-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alimera Sciences
Study Sponsor  ICMJE Alimera Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alimera Sciences
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP