Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results.
OBJECTIVE
To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious posterior uveitis.


METHODS
A 3-year, multicenter, randomized, historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients.


METHODS
Recurrence rate, vision, and complications.


RESULTS
Uveitis recurrence was reduced in implanted eyes from 62% (during the 1-year preimplantation period) to 4%, 10%, and 20% during the 1-, 2-, and 3-year postimplantation periods, respectively, for the 0.59-mg dose group (P < .01) and from 58% to 7%, 17%, and 41%, respectively, for the 2.1-mg dose group (P < .01). More implanted eyes than nonimplanted eyes had improved visual acuity (P < .01). Implanted eyes had higher incidences of intraocular pressure elevation (> or = 10 mm Hg) than nonimplanted eyes (P < .01), and glaucoma surgery was required in 40% of implanted eyes vs 2% of nonimplanted eyes (P < .01). Cataracts were extracted in 93% of phakic implanted eyes vs 20% of phakic nonimplanted eyes (P < .01).


CONCLUSIONS
The FA implant significantly reduced uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious posterior uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure-lowering surgery.


CONCLUSIONS
The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis.


BACKGROUND
clinicaltrials.gov Identifier: NCT00407082.
Callanan
David G
DG
Texas Retina Associates, 1001 N Waldrop Dr, Ste 512, Arlington, TX 76012, USA. dcallanan@texasretina.com
Jaffe
Glenn J
GJ
Martin
Daniel F
DF
Pearson
P Andrew
PA
Comstock
Timothy L
TL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012008:Recurrence; D016896:Treatment Outcome; D015866:Uveitis, Posterior / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity; D014822:Vitreous Body
D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide