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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):

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: fluocinolone acetonide Drug: Fluocinolone Acetonide Procedure: Standard of care laser photocoagulation Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 956 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2007
Primary Completion Date : December 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: fluocinolone acetonide
0.5 mg fluocinolone acetonide intravitreal insert
Experimental: 2 Drug: Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert
Sham Comparator: 3 Procedure: Standard of care laser photocoagulation
Laser photocoagulation


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344968


Locations
United States, Georgia
Atlanta, Georgia, United States
Sponsors and Collaborators
Alimera Sciences
More Information

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00344968     History of Changes
Other Study ID Numbers: C-01-05-001
First Posted: June 27, 2006    Key Record Dates
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs