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

Diabetic Macular Edema Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344968
• Other study ID #: C-01-05-001
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2006
• Last updated: April 8, 2014
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: April 2014
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 956
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• fluocinolone acetonide
0.5 mg fluocinolone acetonide intravitreal insert
• Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert

Procedure:
• Standard of care laser photocoagulation
Laser photocoagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	36 months	Yes
Secondary	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.	36 months	No