Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

NCT00502541 | Completed Phase 2 DMC

• 1 other identifier: CDS FL-005
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

  at 26 weeks and yearly through completion of the study

Study Arms (2)

Fluocinolone acetonide

EXPERIMENTAL

Fluocinolone acetonide intravitreal implant

Drug: fluocinolone acetonide

Standard of Care

ACTIVE COMPARATOR

Standard of care

Procedure: Standard of Care

Interventions

fluocinolone acetonide DRUG

fluocinolone acetonide 0.59 mg intravitreal implant

Fluocinolone acetonide

Standard of Care PROCEDURE

Repeat macular grid laser or observation

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Related Publications (1)

• 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.

  PMID: 16690128 BACKGROUND

MeSH Terms

Interventions

Fluocinolone Acetonide; Standard of Care

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Laura Trusso

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 17, 2007
• Study Start: September 1, 2001
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: November 28, 2013

Record last verified: 2013-11