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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00468871
First received: May 2, 2007
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Non-infectious Uveitis
 Drug: fluocinolone acetonide intravitreal implant
Drug: corticosteroids and immunosuppressants
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Time to first occurrence of uveitis in the study eye. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline. [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Number of recurrences [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Number of recurrences compared to the 52 weeks prior to enrollment [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change in quality of life indices [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Adjunctive treatment required [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change in the size, if present at baseline, of the area of CME on fluorescein angiography [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Analysis of safety variables [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Percent of subjects who had at least one recurrence [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: April 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468871

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00468871     History of Changes
Other Study ID Numbers: 415-002
Study First Received: May 2, 2007
Last Updated: December 7, 2011
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
 Fluocinolone Acetonide
Immunosuppressive Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013