Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468871
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

Condition or disease Intervention/treatment Phase
Non-infectious Uveitis Drug: fluocinolone acetonide intravitreal implant Drug: corticosteroids and immunosuppressants Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluocinolone acetonide
Intravitreal fluocinolone acetonide implant
Drug: fluocinolone acetonide intravitreal implant
surgical intravitreal implant of fluocinolone acetonide
Active Comparator: Standard care
Standard of Care
Drug: corticosteroids and immunosuppressants
Systemic corticosteroids alone or combined with immunosuppressants

Primary Outcome Measures :
  1. Time to first occurrence of uveitis in the study eye. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline. [ Time Frame: 33 months ]
  2. Number of recurrences [ Time Frame: 33 months ]
  3. Number of recurrences compared to the 52 weeks prior to enrollment [ Time Frame: 33 months ]
  4. Change in quality of life indices [ Time Frame: 33 months ]
  5. Adjunctive treatment required [ Time Frame: 33 months ]
  6. Change in the size, if present at baseline, of the area of CME on fluorescein angiography [ Time Frame: 33 months ]
  7. Analysis of safety variables [ Time Frame: 33 months ]
  8. Percent of subjects who had at least one recurrence [ Time Frame: 33 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468871

Sponsors and Collaborators
Bausch & Lomb Incorporated
Principal Investigator: Carlos Pavesio, MD Medical Retina Service/Moorfields Eye Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00468871     History of Changes
Other Study ID Numbers: 415-002
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases
Immunosuppressive Agents
Fluocinolone Acetonide
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists