drugset / Trial / NCT00468871
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.
Timeline
- Start
- 2002-04
- Primary completion
- 2006-06
- Completion
- 2006-06
Outcome
Met primary endpoint
paper Eyes that received the FA intravitreal implant experienced delayed onset of observed recurrence of uveitis (P<0.01) PMID 20079922 ↗
Publications
- Background 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.
- Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisolone | Other / unclassified | 0.1 mg/kg | — |
| Comparator | Prednisolone | Other / unclassified | 0.2 mg/kg | — |
| Subject | fluocinolone acetonide | Other / unclassified | 0.59 mg | Intravitreal |