| December 1, 2006 |
| May 14, 2009 |
| December 2000 |
| September 2005 (final data collection date for primary outcome measure) |
| 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 ] |
- Recurrence of uveitis before and after implantation.
- Uveitis recurrent rates were determined for the 1-year period prior to, and the 34-week, 1-year , 2-year and 3-year periods following implantation.
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| Complete list of historical versions of study NCT00407082 on ClinicalTrials.gov Archive Site |
- 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 ]
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- Between dose comparisons of the rate of uveitis recurrence post-implantation
- Within-subject comparison of Study eye to Fellow eye for recurrence of uveitis post-implantation
- Time to first post-implantation recurrence of uveitis
- The need for adjunctive uveitis treatment for the study eye (pre- versus post-implantation)
- Reduction in the area of cystoid macular edema (CME)
- Results of QOL surveys pre- versus post-implantation
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| |
| Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants |
| 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 |
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. |
| |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Historical Control, Parallel Assignment, Safety/Efficacy Study |
| Noninfectious Posterior Uveitis |
- Drug: fluocinolone acetonide intravitreal implant
- Drug: Fluocinolone acetonide
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- Experimental: Fluocinolone acetonide implant 0.59mg
- Experimental: Fluocinolone acetonide implant 2.1mg
- No Intervention: Fellow eye
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|
| |
| Completed |
| 278 |
| September 2005 |
| September 2005 (final data collection date for primary outcome measure) |
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
|
| Both |
| 6 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00407082 |
| Timothy Comstock, Bausch & Lomb Incorporated |
| 415-001 |
| Bausch & Lomb, Inc. |
|
| Study Director: |
Thomas A Crescuillo |
Bausch & Lomb, Inc. |
|
|
| Bausch & Lomb, Inc. |
| May 2009 |