Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

January 17, 2014 updated by: Alimera Sciences

An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema

This study will evaluate the pharmacokinetics, 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)

37

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins University

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 letters
  • Retinal thickness > 250 microns 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 the last 3 months
  • Prior intravitreal or subtenon anti-VEGF therapy within the last 2 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
Drug: Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert
Experimental: 2
Drug: Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
Drug: Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
Time Frame: over 36 months
This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
over 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinal Thickness
Time Frame: over 36 months
over 36 months

Collaborators and Investigators

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

Sponsor

Alimera Sciences

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

August 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-01-06-002

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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