Original ArticleFluocinolone Acetonide Implant (Retisert) for Noninfectious Posterior Uveitis: Thirty-Four–Week Results of a Multicenter Randomized Clinical Study
Section snippets
Setting
This is a 3-year, prospective, dose-randomized, dose-masked trial in patients with unilateral or bilateral uveitis being conducted at 27 study centers (26 centers in the U.S. and 1 in Singapore). The study protocol was approved by an institutional review board/ethics committee at each study site.
Study Drug
The study was carried out using a linear release (i.e., a constant release rate without plateau) FA intravitreal implant, which was inserted through a pars plana incision. The drug FA is a
Results
Patient recruitment began in November 2000 and concluded in August 2002. Patient demographics are summarized in Table 1. A total of 278 patients were randomized to receive either the 0.59-mg (n = 110) or the 2.1-mg (n = 168) FA implant. There were no significant differences in baseline characteristics between treatment groups. Mean age was 43.5 years (range, 7–84), and 72.3% of patients were female. The mean duration of uveitis before implantation was approximately 7 years.
Discussion
In the present study, the FA implant effectively controlled intraocular inflammation over the 34-week follow-up period, as demonstrated by a significant reduction in the uveitis recurrence rate and decreased need for adjunctive therapy. Furthermore, VA stabilized or improved, generally due to reductions in CME, when compared with the nonimplanted fellow eyes. The efficacy of the 0.59-mg implant did not differ from that of the 2.1-mg implant, suggesting that even with the lower-dose implant,
References (20)
- et al.
Incidence and prevalence of uveitis in northern California. The Northern California Epidemiology of Uveitis Study
Ophthalmology
(2004) - et al.
Clinical patterns and associated conditions in chronic uveitis
Am J Ophthalmol
(1991) - et al.
Intravitreal triamcinolone for uveitic cystoid macular edemaan optical coherence tomography study
Ophthalmology
(2001) - et al.
Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disordersrecommendations of an expert panel
Am J Ophthalmol
(2000) - et al.
Signs and symptoms of uveitisI. Anterior uveitis
Am J Ophthalmol
(1959) - et al.
Echographic localization of corticosteroids after periocular injection
Am J Ophthalmol
(1987) - et al.
Peribulbar corticosteroid injectionvitreal and serum concentrations after dexamethasone disodium phosphate injection
Am J Ophthalmol
(1997) - et al.
Causes and frequency of blindness in patients with intraocular inflammatory disease
Br J Ophthalmol
(1996) - et al.
Immunomodulatory medications in uveitis
Int Ophthalmol Clin
(2004) - et al.
New and emerging treatments for patients with uveitis
Int Ophthalmol Clin
(2000)
Cited by (390)
Thermo-responsive Diels-Alder stabilized hydrogels for ocular drug delivery of a corticosteroid and an anti-VEGF fab fragment
2023, Journal of Controlled ReleaseRecent advances and future prospects: Current status and challenges of the intraocular injection of drugs for vitreoretinal diseases
2023, Advanced Drug Delivery ReviewsComplex ophthalmic formulation technologies: Advancement and future perspectives
2023, Journal of Drug Delivery Science and TechnologyEncapsulation in the ocular system
2023, Principles of Biomaterials Encapsulation: Volume 2Efficacy and safety of intravitreal and periocular injection of corticosteroids in noninfectious uveitis: a systematic review
2022, Survey of OphthalmologyCitation Excerpt :Intravitreal corticosteroids may be applied as injections (often used in more severe cases of cystoid macular edema or vitritis47) or sustained-release implants. The latter allow for the reduction of the frequency of intravitreal injections, and current formulations release dexamethasone (Ozurdex®)21 or fluocinolone acetonide (Retisert®, Yutiq,® and Iluvien®).14,26,27 These regional dosage forms are not without limitations as they may lead to complications, most frequently intraocular pressure (IOP) elevation or cataract progression.4,47
Emerging opportunities for C3 inhibition in the eye
2022, Seminars in Immunology
Manuscript no. 2005-788.
Dr Pearson has a financial interest in Control Delivery Systems, has received consulting fees from Bausch & Lomb, and is listed on patents concerning this technology. Drs Martin and Callanan have received consulting fees from Bausch & Lomb, and Dr Jaffe has received research support from Control Delivery Systems and Bausch & Lomb. Drs Levy and Comstock are employees of Bausch & Lomb.