Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

November 27, 2013 updated by: Bausch & Lomb Incorporated

A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema

This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2
  • Phase 3

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:

  • Males and nonpregnant females at least 18 years of age, with DME in the study eye
  • Edema must involve fixation and be at least 1 disc area in size
  • Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye
  • The study eye must have received at least one macular laser treatment > 12 weeks prior to entry into the study
  • Ability and willingness to comply with treatment and follow-up
  • Ability to understand and sign the Informed Consent form

Exclusion Criteria:

  • Pregnant, lactating females
  • Allergy to fluocinolone acetonide or any component of the delivery system
  • Any disease or condition that would preclude study treatment or follow up
  • Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).
  • History of uncontrolled IOP within the last 12 months

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluocinolone acetonide
Fluocinolone acetonide intravitreal implant
Drug: fluocinolone acetonide
fluocinolone acetonide 0.59 mg intravitreal implant
Active Comparator: Standard of Care
Standard of care
Procedure: Standard of Care
Repeat macular grid laser or observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage
Time Frame: at 26 weeks and yearly through completion of the study
at 26 weeks and yearly through completion of the study

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Laura Trusso, Bausch & Lomb Incorporated

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, 2001

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDS FL-005

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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