RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6µg/day, decreasing over the first month to a steady state between 0.3-0.4 µg/day over approximately 30 months.
RETISERT is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
Published Studies Related to Retisert (Fluocinolone Intravitreal)
Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. [2011.08]
PURPOSE: We studied the 3-year efficacy and safety results of a 4-year study evaluating fluocinolone acetonide (FA) intravitreal implants in eyes with persistent or recurrent diabetic macular edema (DME). DESIGN: Prospective, evaluator-masked, controlled, multicenter clinical trial. PARTICIPANTS: We included 196 eyes with refractory DME... CONCLUSIONS: The FA intravitreal implant met the primary and secondary outcomes, with significantly improved VA and DRSS and reduced DME. The most common AEs included cataract progression and elevated IOP. The 0.59-mg FA intravitreal implant may be an effective treatment for eyes with persistent or recurrent DME. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references. Copyright (c) 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. [2011.04]
OBJECTIVE: To assess the efficacy and safety of intravitreal inserts releasing 0.2 mug/day (low dose) or 0.5 mug/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). DESIGN: Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials. PARTICIPANTS: Subjects with persistent DME despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393)... CONCLUSIONS: Both low- and high-dose FA inserts significantly improved BCVA in patients with DME over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in patients with DME for at least 2 years. Copyright (c) 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Fluocinolone acetonide implantable device for diabetic retinopathy. [2011.03.01]
Diabetic retinopathy remains a major worldwide cause of preventable visual loss. Although photocoagulation and improved metabolic control are effective for patients with diabetic macular edema and proliferative diabetic retinopathy, some patients continue to lose vision despite treatment... Combination photocoagulation and pharmacotherapy with these devices has not yet been reported.
Sustained ocular delivery of fluocinolone acetonide by an intravitreal insert. [2010.07]
PURPOSE: To compare Iluvien intravitreal inserts that release 0.2 or 0.5 microg/day of fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). DESIGN: Prospective, randomized, interventional, multicenter clinical trial. PARTICIPANTS: We included 37 patients with DME... CONCLUSIONS: The FA intravitreal inserts provide excellent sustained intraocular release of FA for > or = 1 year. Although the number of patients in this trial was small, the data suggest that the inserts provide reduction of edema and improvement in BCVA in patients with DME with mild effects on intraocular pressure over the span of 1 year. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. [2010.03]
PURPOSE: To evaluate the safety and efficacy of an intravitreal fluocinolone acetonide (FA) implant compared with standard therapy in subjects with noninfectious posterior uveitis (NIPU). DESIGN: Randomized, controlled, phase 2b/3, open-label, multicenter superiority trial. PARTICIPANTS: Subjects with unilateral or bilateral NIPU... 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. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Clinical Trials Related to Retisert (Fluocinolone Intravitreal)
Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment [Completed]
The purpose of this study is to collect data on patients with severe uveitis that have
required re-implantation of the sustained-release fluocinolone drug delivery device due to
depletion of study drug in their previous implanted device.
A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion [Completed]
The purpose of this study is to determine whether a fluocinolone sustained drug delivery
implant is effective in the treatment of central retinal vein occlusion that has caused
persistent macular edema and decreased visual acuity.
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant [Recruiting]
A Pilot Study on the Effect and Safety of Iluvien� in Chronic Diabetic Macular Edema Patients [Active, not recruiting]
To provide treating physicians with experience with ILUVIEN as well as monitoring its safety
(and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged
insufficiently responsive to available therapies.
Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis [Enrolling by invitation]
The purpose of this study is to determine the tolerability, safety, and benefits of an
investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have
posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical
implant, Retisert, which is approved by the U. S. Food and Drug Administration (FDA) to treat
non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology
(eye)clinic whereas Retisert must be surgically implanted in the Operating Room. Two doses
of fluocinolone acetonide will be used in this study to determine if either strength of
fluocinolone acetonide can effectively treat uveitis and if so, which strength works better.
Or, it is possible that both strengths may work about the same but one strength may have
fewer side effects.
Page last updated: 2011-12-09