Intravitreal Fluocinolone Acetonide (Retisert) Implantation Using a Keratome Blade.
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ABSTRACT:
SUBMITTER: Pasricha MV
PROVIDER: S-EPMC9976051 | biostudies-literature | 2021 Jan-Feb
REPOSITORIES: biostudies-literature
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Intravitreal Fluocinolone Acetonide (Retisert) Implantation Using a Keratome Blade.
Pasricha Malini Veerappan MV Callaway Natalia F NF Mahajan Vinit B VB
Journal of vitreoretinal diseases 20200917 1
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Project description:IntroductionThe 0.19 mg fluocinolone acetonide (FAc) intravitreal implant delivers a continuous intravitreal corticosteroid dose for the treatment of refractory diabetic macular oedema (DMO). The aim of this study was to assess the impact of an FAc intravitreal implant on intraocular pressure (IOP).MethodsWe retrospectively collected anonymised data on the patients' characteristics, DMO treatment, and IOP and IOP-lowering treatments before and after the FAc intravitreal implant between September 2013 and March 2020 in several European centres.ResultsA total of 221 eyes from 179 patients were included. The mean follow-up duration was 13.4 (± 12.5, range 2.4-33.5) months. Overall, 194 eyes (88.2%) had received an intravitreal dexamethasone injection before the FAc intravitreal implant. For 25 eyes (11.3%) there was a history of glaucoma, and 52 eyes (23.5%) had previous IOP-lowering treatment. Mean IOP before injection was 14.7 (3.4) mmHg and increased to 16.9 (3.7) mmHg 12 months after injection (P < 0.0001). During follow-up, 55 eyes (24.9%) required the addition or initiation of topical IOP-lowering medication, only one patient (0.5%) had laser trabeculoplasty and one patient (0.5%) a minimally invasive glaucoma surgery, and no patient required incisional IOP-lowering surgery.ConclusionThe FAc intravitreal implant led to substantial IOP elevation. This elevation was monitored most of the time with addition or initiation of topical IOP-lowering medication.
| S-EPMC9114211 | biostudies-literature
Project description:Uveitis is a major cause of ocular morbidity, potentially leading to significant visual impairment. The recent adoption of alternative drug delivery options has led to the development of new sustained-delivery corticosteroid systems, able to manage successfully chronic noninfectious posterior uveitis. The treatment goal is to target the site of inflammation with low dose of corticosteroids, delivered over an extended period of time, to minimize the cumulative damage resulting from repeated recurrences, reducing both injections frequency and ocular side effects. This article will review the pharmacology and preliminary clinical data of the 0.18 mg fluocinolone acetonide intravitreal implant (YUTIQ™), to show its efficacy and safety in the treatment of noninfectious posterior uveitis.
| S-EPMC6880290 | biostudies-literature
Project description:Diabetic macular edema (DME) is now a well-known condition for which a number of treatments have been shown to be effective. Intraocular corticosteroids are part of this therapeutic arsenal but are sometimes responsible for ocular hypertension. We describe here the case of a 60-year-old man with a history of bilateral DME who received an intravitreal injection of 190 µg fluocinolone acetonide (FAc) (ILUVIEN®, Alimera Sciences, Alpharetta, GA, USA) who presented a persistent ocular hypertension in one eye despite FAc removal by pars plana vitrectomy and was successfully managed by Preserflo® microshunt surgery.
| S-EPMC9808306 | biostudies-literature
Project description:IntroductionThis case study aims to evaluate outcomes following fluocinolone acetonide [FAc 0.2 μg/day; ILUVIEN(®) (Alimera Sciences Limited, Aldershot, UK)] implant in a patient with diabetic macular edema (DME) not responding to laser photocoagulation or anti-vascular endothelial growth factor (anti-VEGF) therapy and to compare FAc implant with anti-VEGF therapy in the fellow eye.Case reportThe author presents here a patient with DME for around 20 years in both eyes, who had undergone pan-retinal and focal photocoagulation, and anti-VEGF therapy in both eyes without resolution of DME. FAc implant in the left, and subsequently in the right eye, provided substantial improvements in edema and visual acuity.ConclusionIn the current case, a benefit was demonstrated in the FAc implant-treated left eye at a time when the right eye was not responding to anti-VEGF injections. If a patient does not respond well to an anti-VEGF (i.e. first-line therapy) in one eye, the treating physician should consider switching the patient to a corticosteroid implant (such as FAc implant) in the fellow eye.
| S-EPMC4470980 | biostudies-literature
Project description:AimsTo compare safety outcomes and visual function data acquired in the real-world setting with FAME study results in eyes treated with 0.2 μg/day fluocinolone acetonide (FAc).MethodsFourteen UK clinical sites contributed to pseudoanonymised data collected using the same electronic medical record system. Data pertaining to eyes treated with FAc implant for diabetic macular oedema (DMO) was extracted. Intraocular pressure (IOP)-related adverse events were defined as use of IOP-lowering medication, any rise in IOP>30 mm Hg, or glaucoma surgery. Other measured outcomes included visual acuity, central subfield thickness (CSFT) changes and use of concomitant medications.ResultsIn total, 345 eyes had a mean follow-up of 428 days. Overall, 13.9% of patients required IOP-lowering drops (included initiation, addition and switching of current drops), 7.2% had IOP elevation >30 mm Hg and 0.3% required glaucoma surgery. In patients with prior steroid exposure and no prior IOP-related event, there were no new IOP-related events. In patients without prior steroid use and without prior IOP-related events, 10.3% of eyes required IOP-lowering medication and 4.3% exhibited IOP >30 mm Hg at some point during follow-up. At 24 months, mean best-recorded visual acuity increased from 51.9 to 57.2 letters and 20.8% achieved ≥15-letter improvement. Mean CSFT reduced from 451.2 to 355.5 μm.ConclusionsWhile overall IOP-related emergent events were observed in similar frequency to FAME, no adverse events were seen in the subgroup with prior steroid exposure and no prior IOP events. Efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO.
| S-EPMC5733285 | biostudies-literature
Project description:IntroductionBlau syndrome is a progressive disease with an unknown etiology and pathogenesis. It can cause severe damage, especially in the eye with severe involvement.Case presentationA six-year-old female was referred to us complaining about blurry vision and floaters in both eyes for 1 year. She had been diagnosed with Blau syndrome and Blau syndrome-associated anterior uveitis. Her best-corrected visual acuity in the right and left eyes was 20/70 and 20/80, respectively. Slit-lamp exam revealed faint bilateral band keratopathy along with 1+ anterior chamber cells and posterior synechia 360° in both eyes. During dilated fundoscopy, 2+ haze in the media was observed, along with swollen and hyperemic disc OU. Based on changes in optical coherence tomography, fluorescein angiography, and indocyanine green angiography, she was diagnosed with panuveitis and retinal vasculitis. Given her complicated history, we decided to proceed with an intravitreal fluocinolone acetonide 0.19 mg implant implantation in both eyes. During the 1-month follow-up visit, vitreous haze, retinal vasculitis, and active choroiditis were resolved. At 6-month follow-up visit, no changes were observed compared to the 1-month follow-up visit.ConclusionIn cases of Blau syndrome that display resistance to systemic immunomodulatory therapies, the inclusion of local treatments, such as the intravitreal fluocinolone acetonide 0.19 mg implant, should be considered as an adjunctive therapeutic option.
| S-EPMC10798681 | biostudies-literature
Project description:AimsThe ILUVIEN Registry Safety Study is an ongoing, multicentre, open-label, observational study collecting real-world data on the safety and effectiveness of the 0.2 µg/day fluocinolone acetonide (FAc) implant in patients treated according to the European label requirements.MethodsPatients included in this analysis were treated for the licensed indication of chronic diabetic macular oedema (cDMO; that is, DMO that persists or recurs despite treatment). Data presented in the current analysis were collected from patient records up to 6 March 2017. Visual acuity (VA) data, including mean change in VA over time and at last observation, intraocular pressure (IOP) over the course of the study, IOP events, use of IOP-lowering therapy and cup:disc ratio were analysed. Information on additional DMO treatments post-FAc implant was also captured.ResultsFive hundred and sixty-three patients (593 eyes) were enrolled on the study. Mean IOP for the overall population remained within the normal range throughout follow-up and 76.7% of patients did not require IOP-lowering therapy following treatment with the FAc implant. Sixty-nine per cent of eyes did not require additional DMO treatments. Mean VA in the overall population increased from 51.9 letters at baseline to 55.6 letters at month 12, with a significant increase of 2.9 letters at last observation. Patients with short-term cDMO experienced greater VA gains than those with long-term cDMO.ConclusionsThe results of this analysis are comparable with those of other studies, including the Fluocinolone Acetate for Macular Edema study. The study reinforces the good safety and effectiveness profile of FAc, and demonstrates the benefit of early FAc treatment.
| S-EPMC6678053 | biostudies-literature
Project description:Background/purposeTo describe two cases of patients diagnosed with chronic postoperative cystoid macular edema associated with noninfectious posterior uveitis who had limited treatment response to previous corticosteroid modalities and then received a single intravitreal fluocinolone 0.18-mg implant. Chronic postoperative cystoid macular edema (CME) may occur after intraocular surgery and is a common cause of postoperative visual loss. Sometimes called Irvine-Gass syndrome or persistent pseudophakic CME, chronic postoperative CME complicates roughly 0.1% to 2.0% of low-risk, small-incision phacoemulsification surgeries. There are a number of conventional approaches to chronic postoperative CME management, including topical corticosteroids with or without nonsteroidal anti-inflammatory drugs, intravitreal corticosteroid injections, and vascular endothelial growth factor (VEGF) inhibitor injections, but these options have several limitations. A major shortcoming of conventional formulations of anti-inflammatory therapies for chronic postoperative CME (i.e., topical drops, intraocular, and periocular injections) is the need for repeated dosing in chronic cases, which is expensive and burdensome to patients.MethodsSeries of two case reports. Patient 1, a 75-year-old Latina woman, presented with a history of longstanding, recurrent inflammation after cataract extraction and subsequent vitreoretinal surgeries. Patient 2, an 85-year-old white woman, presented with acute blurred vision, swelling, and pain 5 years after cataract surgery and laser peripheral iridotomy. Both were diagnosed with chronic postoperative CME and ultimately treated with the 3-year sustained-release fluocinolone acetonide intravitreal implant (FAi) 0.18 mg.ResultsCompared with baseline, both patients experienced resolution of their disease symptoms, >3 lines of visual acuity improvement, and macular edema reduction of 56.2% and 38.4% at 15 and 6 months, respectively, after the fluocinolone implant. No steroid related adverse events including any intraocular pressure measurement >25 mmHg were observed.ConclusionA single intravitreal fluocinolone 0.18-mg implant can effectively and safely treat vision loss and increased central macular thickness because of chronic postoperative cystoid macular edema associated with noninfectious posterior uveitis. The FAi 0.18 mg provides a safe, long-acting, low-dose anti-inflammatory treatment in patients with noninfectious posterior-segment inflammation associated with chronic postoperative CME.
| S-EPMC11302583 | biostudies-literature
Project description:PurposeDiabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2 μg/day FAc implant.MethodsThis analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.ResultsBest corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥ 3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.ConclusionsThese data support the use of 0.2 μg/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.
| S-EPMC4565956 | biostudies-literature
Project description:BackgroundPrevention of non-infectious uveitis of the posterior segment (NIU-PS) recurrence using 0.2 μg/day fluocinolone acetonide implant (FAi) was assessed over 3 years (NCT01694186). Outcomes for FAi-treated and fellow eyes with NIU-PS were compared, to evaluate FAi versus conventional treatment strategies.MethodsEligible subjects had >1-year recurrent NIU-PS history and either ≥2 separate recurrences requiring treatment, or corticosteroid therapy (systemic or ocular) in the 12 months preceding study entry. Bilateral disease was present and analysed in 59/87 FAi-treated participants. Recurrence rates, best-corrected visual acuity (BCVA) changes, cataract surgery, intraocular pressure (IOP) events and adjunctive medication use were compared for FAi-treated and fellow eyes.ResultsOver 36 months, more FAi-treated than fellow eyes remained recurrence-free (28.8% vs. 5.1%, P = 0.001; mean 1.9 vs. 4.7 recurrences, respectively, P < 0.0001). FAi-treated eyes gained +9.6 letters BCVA, versus a loss of -4.4 in fellow eyes (P < 0.0001). Systemic medications were given to 42.4% of subjects. Intra/periocular adjunctive injections were lower in FAi-treated than fellow eyes (20.3% vs. 66.1%, P < 0.0001); topical corticosteroid use was also lower in FAi-treated than fellow eyes (27.1% vs 52.5%, P = 0.0041). IOP-related events occurred at similar rates in both FAi-treated and fellow eyes, excepting IOP-lowering surgery (5.1% vs. 15.3%, respectively; P = 0.1251). Cataract surgery occurred in 72.0% of FAi-treated and 37.0% of fellow eyes.ConclusionsIn subjects with bilateral NIU-PS, continuous, low-dose corticosteroid with 0.2 μg/day FAi reduced recurrence and adjunctive medication requirements, and improved vision over 36 months, providing greater protection against ocular inflammation than a reactive approach using standard of care.
| S-EPMC9151815 | biostudies-literature