search
Back to results

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

Primary Purpose

Non-infectious Uveitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluocinolone acetonide intravitreal implant
corticosteroids and immunosuppressants
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-infectious Uveitis

Eligibility Criteria

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

Inclusion Criteria:

  • Males and non-pregnant females at least 6 years of age
  • History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
  • The more severely affected eye having had at least 2 separate recurrences
  • The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion
  • Visual acuity (VA) of at least 1.4 logMAR units at enrollment
  • At time of enrollment, </=10 anterior chamber cells/HPF and vitrous haze</= grade 2.

Exclusion Criteria:

  • known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
  • history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
  • presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP >25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to <25 mm Hg
  • history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
  • infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
  • ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment
  • monocularity
  • AIDS
  • pregnancy/lactation
  • potential for noncompliance
  • or participation in other clinical studies within 1 month of enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fluocinolone acetonide

    Standard care

    Arm Description

    Intravitreal fluocinolone acetonide implant

    Standard of Care

    Outcomes

    Primary Outcome Measures

    Time to first occurrence of uveitis in the study eye.

    Secondary Outcome Measures

    The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
    Number of recurrences
    Number of recurrences compared to the 52 weeks prior to enrollment
    Change in quality of life indices
    Adjunctive treatment required
    Change in the size, if present at baseline, of the area of CME on fluorescein angiography
    Analysis of safety variables
    Percent of subjects who had at least one recurrence

    Full Information

    First Posted
    May 2, 2007
    Last Updated
    December 7, 2011
    Sponsor
    Bausch & Lomb Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00468871
    Brief Title
    Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
    Official Title
    A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 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 is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-infectious Uveitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluocinolone acetonide
    Arm Type
    Experimental
    Arm Description
    Intravitreal fluocinolone acetonide implant
    Arm Title
    Standard care
    Arm Type
    Active Comparator
    Arm Description
    Standard of Care
    Intervention Type
    Drug
    Intervention Name(s)
    fluocinolone acetonide intravitreal implant
    Intervention Description
    surgical intravitreal implant of fluocinolone acetonide
    Intervention Type
    Drug
    Intervention Name(s)
    corticosteroids and immunosuppressants
    Intervention Description
    Systemic corticosteroids alone or combined with immunosuppressants
    Primary Outcome Measure Information:
    Title
    Time to first occurrence of uveitis in the study eye.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
    Time Frame
    33 months
    Title
    Number of recurrences
    Time Frame
    33 months
    Title
    Number of recurrences compared to the 52 weeks prior to enrollment
    Time Frame
    33 months
    Title
    Change in quality of life indices
    Time Frame
    33 months
    Title
    Adjunctive treatment required
    Time Frame
    33 months
    Title
    Change in the size, if present at baseline, of the area of CME on fluorescein angiography
    Time Frame
    33 months
    Title
    Analysis of safety variables
    Time Frame
    33 months
    Title
    Percent of subjects who had at least one recurrence
    Time Frame
    33 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and non-pregnant females at least 6 years of age History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease The more severely affected eye having had at least 2 separate recurrences The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion Visual acuity (VA) of at least 1.4 logMAR units at enrollment At time of enrollment, </=10 anterior chamber cells/HPF and vitrous haze</= grade 2. Exclusion Criteria: known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP >25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to <25 mm Hg history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment monocularity AIDS pregnancy/lactation potential for noncompliance or participation in other clinical studies within 1 month of enrollment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Pavesio, MD
    Organizational Affiliation
    Medical Retina Service/Moorfields Eye Hospital
    Official's Role
    Principal Investigator

    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
    background
    PubMed Identifier
    20079922
    Citation
    Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.
    Results Reference
    derived

    Learn more about this trial

    Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

    We'll reach out to this number within 24 hrs