Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00502541
First received: July 13, 2007
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: fluocinolone acetonide
Procedure: Standard of Care
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: September 2001
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502541

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Laura Trusso Bausch & Lomb Incorporated
  More Information

Publications:
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00502541     History of Changes
Obsolete Identifiers: NCT00031525
Other Study ID Numbers: CDS FL-005
Study First Received: July 13, 2007
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014