Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis.
OBJECTIVE
To evaluate the safety and efficacy of an intravitreal fluocinolone acetonide (FA) implant compared with standard therapy in subjects with noninfectious posterior uveitis (NIPU).


METHODS
Randomized, controlled, phase 2b/3, open-label, multicenter superiority trial.


METHODS
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).


METHODS
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.
Pavesio
Carlos
C
Medical Retina Service/Moorfields Eye Hospital, London, UK. carlos.pavesio@moorfields.nhs.uk
Zierhut
Manfred
M
Bairi
Khaled
K
Comstock
Timothy L
TL
Usner
Dale W
DW
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D004343:Drug Implants; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome; D015866:Uveitis, Posterior / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body; D055815:Young Adult
D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide