Clinical trial NCT00407082: Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Noninfectious Posterior Uveitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 278
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Recurrence of uveitis before and after implantation.
timeFrame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
Secondary outcomes:
measure: Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: Results of QOL surveys pre- versus post-implantation
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: Time to recurrence, between treatment group comparison
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
measure: Post implantation uveitis rate, between treatment group comparison
timeFrame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Thomas A Crescuillo
role: STUDY_DIRECTOR
References:
citation: Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
citation: Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191.