A Phase 2/3 interventional study of fluocinolone acetonide intravitreal implant and Fluocinolone acetonide 2.1mg in Noninfectious Posterior Uveitis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2011-12-08.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 2/3, Interventional, and Treatment
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.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's enrollment of 278 is above the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Fluocinolone acetonide ocular implant 0.59mg
Drug: fluocinolone acetonide intravitreal implant
Fluocinolone acetonide ocular implant 2.1mg
Drug: Fluocinolone acetonide 2.1mg
Fellow eye
Fluocinolone acetonide ocular implant 0.59mg
Fluocinolone acetonide ocular implant 2.1mg
Recurrence of uveitis before and after implantation.
Time frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
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
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
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
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
Results of QOL surveys pre- versus post-implantation
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
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
Time to recurrence, between treatment group comparison
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Post implantation uveitis rate, between treatment group comparison
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluocinolone Acetonide