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

April 8, 2014 updated by: Alimera Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

956

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimera Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-01-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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