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Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluocinolone acetonide
Standard of Care
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fluocinolone acetonide

    Standard of Care

    Arm Description

    Fluocinolone acetonide intravitreal implant

    Standard of care

    Outcomes

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2007
    Last Updated
    November 27, 2013
    Sponsor
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00502541
    Brief Title
    Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    September 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    196 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluocinolone acetonide
    Arm Type
    Experimental
    Arm Description
    Fluocinolone acetonide intravitreal implant
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    Standard of care
    Intervention Type
    Drug
    Intervention Name(s)
    fluocinolone acetonide
    Intervention Description
    fluocinolone acetonide 0.59 mg intravitreal implant
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Repeat macular grid laser or observation
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura Trusso
    Organizational Affiliation
    Bausch & Lomb Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16690128
    Citation
    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.
    Results Reference
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    Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

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