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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00407082
First received: December 1, 2006
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Condition Intervention Phase
Noninfectious Posterior Uveitis
 Drug: fluocinolone acetonide intravitreal implant
Drug: Fluocinolone acetonide 2.1mg
 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, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Recurrence of uveitis before and after implantation. [ Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Results of QOL surveys pre- versus post-implantation [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Time to recurrence, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Post implantation uveitis rate, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]

Enrollment: 278
Study Start Date: December 2000
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluocinolone acetonide 0.59mg
Fluocinolone acetonide ocular implant 0.59mg
 Drug: fluocinolone acetonide intravitreal implant
Fluocinolone acetonide ocular implant 0.59mg
Experimental: Fluocinolone acetonide 2.1mg
Fluocinolone acetonide ocular implant 2.1mg
 Drug: Fluocinolone acetonide 2.1mg
Fluocinolone acetonide ocular implant 2.1mg
No Intervention: No intervention
Fellow eye

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, and had 'quiet' eyes at surgery

Exclusion Criteria:

  • Coexisting medical or ocular conditions that would interfere with the study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407082

Locations
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Thomas A Crescuillo Bausch & Lomb Incorporated
  More Information

Publications:

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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00407082     History of Changes
Other Study ID Numbers: 415-001
Study First Received: December 1, 2006
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveitis, Posterior
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
 Panuveitis
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 May 23, 2013