Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

This study has been terminated.
(SARS epidemic in Asia and Canada)
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00456482
First received: April 3, 2007
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide 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
Non-infectious Uveitis
Drug: Fluocinolone Acetonide 0.59mg
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
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye. [ Time Frame: 1 year pre-implantation; 3 years post-implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys. [ Time Frame: 1 year pre-implantation; 3 years post-implantation ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: May 2002
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluocinolone Acetonide 0.59mg
Fluocinolone acetonide intravitreal implant 0.59mg
Drug: Fluocinolone Acetonide 0.59mg
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Experimental: Fluocinolone Acetonide 2.1mg
Fluocinolone acetonide intravitreal implant 2.1mg
Drug: Fluocinolone Acetonide 2.1mg
Fluocinolone Acetonide Intravitreal Implant 2.1 mg
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,
  • Had clinically 'quiet' eyes at surgery.

Exclusion Criteria:

  • Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456482

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Timothy L Comstock, OD Bausch & Lomb Incorporated
  More Information

Publications:
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00456482     History of Changes
Other Study ID Numbers: 415-004
Study First Received: April 3, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
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 July 26, 2014