Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502541
• Other study ID #: CDS FL-005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 13, 2007
• Last updated: November 27, 2013
• Start date: September 2001
• Est. completion date: September 2006

Study information

• Verified date: November 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00031525

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• fluocinolone acetonide
fluocinolone acetonide 0.59 mg intravitreal implant

Procedure:
• Standard of Care
Repeat macular grid laser or observation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

References & 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. Epub 2006 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No