Intraocular Pressure in Patients With Uveitis Treated With Fluocinolone Acetonide Implants

Abstract

To report the incidence and management of elevated intraocular pressure (IOP) in patients with uveitis treated with the fluocinolone acetonide (FA) intravitreal implant. Design: Pooled data from 3 multicenter, doublemasked, randomized, controlled, phase 2b/3 clinical trials evaluating the safety and efficacy of the 0.59-mg or 2.1-mg FA intravitreal implant or standard therapy were analyzed. Results: During the 3-year follow-up, 71.0% of implanted eyes had an IOP increase of 10 mm Hg or more than baseline and 55.1%, 24.7%, and 6.2% of eyes reached an IOP of 30 mm Hg or more, 40 mm Hg or more, and 50 mm Hg or more, respectively. Topical IOP-lowering medication was administered in 74.8% of implanted eyes, and IOP-lowering surgeries, most of which were trabeculectomies (76.2%), were performed on 36.6% of implanted eyes. Intraocular pressure-loweringsurgerieswereconsideredasuccess(postoperative IOP of 6-21 mm Hg with or without additional IOP-lowering medication) in 85.1% of eyes at 1 year. The rate of hypotony (IOPՅ5 mm Hg) following IOP-lowering surgery (42.5%) was not different from that of implanted eyes not subjected to surgery (35.4%) (P=.09). Conclusion: Elevated IOP is a significant complication with the FA intravitreal implant but may be controlled with medication and surgery.

Outcomes of Birdshot Chorioretinopathy Treated With an Intravitreal Sustained-Release Fluocinolone Acetonide–Containing Device

“…21 In a larger series of 584 eyes, including many of the same patients, topical IOP-lowering medications were required in 74.8% of implanted eyes, and IOP-lowering surgeries were performed in 36.6% of implanted eyes by three years. 28 Of the 31 patients in our study with ascertainable outcomes, all required medical therapy (100%), and 12 required glaucoma surgery (33%). Both new medical treatment and new surgeries peaked at 12 months when most patients were still being followed.…”

Corticosteroid implants for chronic non-infectious uveitis

“…The study compared FA intravitreal implant with sham injection CTRI/2014/12/005337 Did not compare fluocinolone or dexamethasone implant with standard-of-therapy. The study compared FA intravitreal implant with sham injection Eng 2007 Wrong type of participants were included; did not assess non-infectious posterior uveitis, intermediate uveitis, or panuveitis Ermakova 2003 Not a RCT. Galor 2007 Not a RCT. Garg 2006 Not a RCT. Goldstein 2007 Did not compare fluocinolone or dexamethasone implant with standard-of-therapy. The study compared 0.59-mg FA intravitreal implant with 2.1-mg FA intravitreal implant Ibrahim 2009 Not a RCT. Jaffe 2000a Not a RCT. Jaffe 2000b Not a RCT. Jaffe 2005a Did not compare fluocinolone or dexamethasone implant with standard-of-therapy.…”

“…There is also a non-biodegradable fluocinolone acetonide implant for diabetic edema (Campochiaro 2010), which has been investigated for posterior uveitis. While such implants may reduce the overall systemic impact of corticosteroids, the increased intraocular exposure may cause higher rates of cataract and glaucoma (Bollinger 2011; Goldstein 2007a; Kempen 2011a; Pavesio 2010a), and these risks need to be weighed against their potential benefits.…”

Model systems for the study of steroid-induced IOP elevation

“…Intraocular steroids increase the risk for IOP elevation dramatically. In trials of sustained release fluocinolone acetonide implant, over 75% of patients receiving the steroid intravitreally required IOP lowering therapy and 40% required surgical intervention for IOP control (Goldstein et al, 2007). The prevalence of steroid–induced IOP elevation is even higher among patients with glaucoma.…”