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Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

NCT ID: NCT00502541

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluocinolone acetonide

Fluocinolone acetonide intravitreal implant

Group Type EXPERIMENTAL

fluocinolone acetonide

Intervention Type DRUG

fluocinolone acetonide 0.59 mg intravitreal implant

Standard of Care

Standard of care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type PROCEDURE

Repeat macular grid laser or observation

Interventions

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fluocinolone acetonide

fluocinolone acetonide 0.59 mg intravitreal implant

Intervention Type DRUG

Standard of Care

Repeat macular grid laser or observation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Trusso

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

References

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Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.

Reference Type BACKGROUND
PMID: 16690128 (View on PubMed)

Other Identifiers

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CDS FL-005

Identifier Type: -

Identifier Source: org_study_id

NCT00031525

Identifier Type: -

Identifier Source: nct_alias