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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00344968
First received: June 26, 2006
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Alimera Sciences:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 956
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344968

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

No publications provided

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00344968     History of Changes
Other Study ID Numbers: C-01-05-001
Study First Received: June 26, 2006
Results First Received: September 27, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014