Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis.

Détails

ID Serval
serval:BIB_F0B11CFF5476
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis.
Périodique
Ophthalmology
Auteur(s)
Pavesio C., Zierhut M., Bairi K., Comstock T.L., Usner D.W.
Collaborateur(s)
Fluocinolone Acetonide Study Group
ISSN
1549-4713[electronic], 0161-6420[linking]
Statut éditorial
Publié
Date de publication
2010
Peer-reviewed
Oui
Volume
117
Numéro
3
Pages
567-75, 575.e1
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Investigators List: Abboud (Emad) E ; Amoaku (Winfried) W ; Becker (Matthias) M ; Brancato (Rosario) R ; Benitez del Castillo (Jose M) JM ; Calonge (Margarita) M ; Carmona (Manuela) M ; Marano (Ricardo Casaroli) RC ; Caspers-Velu (Laure) L ; Llopis (Manuel Diaz) MD ; de Smet (Marc) M ; Dick (Andrew) A ; Eldem (Bora) B ; Figueroa (Marta) M ; Forrester (John) J ; Frau (Eric) E ; Garcia-Arumi (Jose) J ; Gavin (Mike) M ; Graham (Elizabeth) E ; Guembel (Hermann) H ; Guex-Crosier (Yan) Y ; Hansen (Lutz) L ; Heiligenhaus (Arnd) A ; Herbort (Carl P) CP ; Kestelyn (Philippe) P ; Kilmartin (Dara) D ; Koch (Frank) F ; Korobelnik (Jean-Francois) JF ; Labalette (Pierre) P ; Hoang (Phuc Le) PL ; Dos Reis (Fernando Manuel Mendes Falco) FM ; Murray (Philip) P ; Navea (Amparo) A ; Neumann (Ron) R ; Orsoni (Gabriella Jelka) GJ ; Pavesio (Carlos) C ; Pivetti-Pezzi (Paola) P ; Pleyer (Uwe) U ; Sartani (Gil) G ; Secchi (Antonio) A ; Silvestri (Giuliana) G ; Thurau (Stephan) S ; Weber (Michel) M ; Zierhut (Manfred) M ; Brucker (Alexander) A ; Gehrs (Karen) K ; Jampol (Lee) L ; Johnson (Mark) M ; Colton (Theodore) T ; Musch (David) D ; Levine (Robert) R ;
Résumé
PURPOSE: To evaluate the safety and efficacy of an intravitreal fluocinolone acetonide (FA) implant compared with standard therapy in subjects with noninfectious posterior uveitis (NIPU). DESIGN: Randomized, controlled, phase 2b/3, open-label, multicenter superiority trial. PARTICIPANTS: Subjects with unilateral or bilateral NIPU. METHODS: One hundred forty subjects received either a 0.59-mg FA intravitreal implant (n = 66) or standard of care (SOC; n = 74) with either systemic prednisolone or equivalent corticosteroid as monotherapy (> or =0.2 mg/kg daily) or, if judged necessary by the investigator, combination therapy with an immunosuppressive agent plus a lower dose of prednisolone or equivalent corticosteroid (> or =0.1 mg/kg daily). MAIN OUTCOME MEASURES: Time to first recurrence of uveitis. RESULTS: Eyes that received the FA intravitreal implant experienced delayed onset of observed recurrence of uveitis (P<0.01) and a lower rate of recurrence of uveitis (18.2% vs. 63.5%; P< or =0.01) compared with SOC study eyes. Adverse events frequently observed in implanted eyes included elevated intraocular pressure (IOP) requiring IOP-lowering surgery (occurring in 21.2% of implanted eyes) and cataracts requiring extraction (occurring in 87.8% of phakic implanted eyes). No treatment-related nonocular adverse events were observed in the implant group, whereas such events occurred in 25.7% of subjects in the SOC group. CONCLUSIONS: The FA intravitreal implant provided better control of inflammation in patients with uveitis compared with systemic therapy. Intraocular pressure and lens clarity of implanted eyes need close monitoring in patients receiving the FA intravitreal implant.
Mots-clé
Adolescent, Adult, Aged, Child, Drug Implants, Female, Fluocinolone Acetonide/administration & dosage, Fluocinolone Acetonide/adverse effects, Glucocorticoids/administration & dosage, Glucocorticoids/adverse effects, Humans, Male, Middle Aged, Recurrence, Treatment Outcome, Uveitis, Posterior/drug therapy, Uveitis, Posterior/physiopathology, Visual Acuity/physiology, Vitreous Body, Young Adult
Pubmed
Web of science
Création de la notice
30/03/2010 15:44
Dernière modification de la notice
19/03/2018 12:21
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