| Abstract | OBJECTIVES: To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious posterior uveitis. DESIGN: 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. MAIN OUTCOME MEASURES: 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. APPLICATION TO CLINICAL PRACTICE: The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00407082. |
| Authors | David G Callanan, Glenn J Jaffe, Daniel F Martin, P Andrew Pearson, Timothy L Comstock
(Affiliation: Texas Retina Associates, 1001 N Waldrop Dr, Ste 512, Arlington, TX 76012, USA. dcallanan at texasretina.com)
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| Journal | Archives of ophthalmology
(Arch Ophthalmol)
Vol. 126
Issue 9
Pg. 1191-201
(Sep 2008)
ISSN: 1538-3601 United States |
| PMID | 18779477
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
- Drug Implants
- Glucocorticoids
- Fluocinolone Acetonide
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| Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Child
- Double-Blind Method
- Drug Implants
- Female
- Fluocinolone Acetonide
(administration & dosage, adverse effects)
- Follow-Up Studies
- Glucocorticoids
(administration & dosage, adverse effects)
- Humans
- Intraocular Pressure
- Male
- Middle Aged
- Postoperative Complications
- Recurrence
- Treatment Outcome
- Uveitis, Posterior
(drug therapy, physiopathology)
- Visual Acuity
- Vitreous Body
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