ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

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.
ClinicalTrials.gov Identifier: NCT00407082
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Noninfectious Posterior Uveitis Drug: fluocinolone acetonide intravitreal implant Drug: Fluocinolone acetonide 2.1mg Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2000
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Recurrence of uveitis before and after implantation. [ Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Results of QOL surveys pre- versus post-implantation [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ]
  6. 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 ]
  7. Time to recurrence, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ]
  8. Post implantation uveitis rate, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Uveitis
Uveitis, Posterior
Uveal Diseases
Eye Diseases
Panuveitis
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs