Back to resultsFluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema (FAME)
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
fluocinolone acetonide
Fluocinolone Acetonide
Standard of care laser photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Visual Acuity
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).
Secondary Outcome Measures
Retinal Thickness
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00344968
Brief Title
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Acronym
FAME
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alimera Sciences
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
956 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
fluocinolone acetonide
Intervention Description
0.5 mg fluocinolone acetonide intravitreal insert
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide
Intervention Description
0.2 mg fluocinolone acetonide intravitreal insert
Intervention Type
Procedure
Intervention Name(s)
Standard of care laser photocoagulation
Intervention Description
Laser photocoagulation
Primary Outcome Measure Information:
Title
Visual Acuity
Description
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).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Retinal Thickness
Description
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Atlanta
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33206392
Citation
Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
Results Reference
derived
PubMed Identifier
30569759
Citation
Holden SE, Kapik B, Beiderbeck AB, Currie CJ. Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials. Curr Med Res Opin. 2019 Jul;35(7):1165-1176. doi: 10.1080/03007995.2018.1560779. Epub 2019 Jan 17.
Results Reference
derived
Learn more about this trial
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
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