Dataset Information

Efficacy of 0.2??g/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy.

ABSTRACT: PurposeLimited data are available on the efficacy of the 0.2??g/day fluocinolone acetonide (FAc) implant in eyes with prior vitrectomy. Here, we present a collection of 26 vitrectomized eyes treated with the 0.2??g/day FAc implant.MethodsRetrospective study involving six centers from four European countries analyzing the safety and efficacy data from patients (26 eyes from 25 patients) with DME and a prior vitrectomy that had been treated with one 0.2??g/day FAc implant.ResultsPrior intravitreal therapies included anti-VEGF (mean, 3.8 injections) and steroids (mean, 1.9 injections). Pars plana vitrectomy (PPV) was performed in these eyes primarily for abnormalities of vitreoretinal interface, followed by proliferative diabetic retinopathy and vitreous hemorrhage. The 0.2??g/day FAc implant was injected 24.2 months, on average, after PPV and the mean duration of follow-up after injection was 255 days (range, 90 to 759 days). The mean change in BCVA was +11.7 ETDRS letters (range, -19 to +40 letters; P<0.0004) and the mean change in central foveal thickness (CFT) was -233.5??m (range, -678 to 274??m; P<0.0001). The mean change in IOP from baseline at the last visit was +1.4?mm?Hg (range, -9 to +8?mm?Hg; P=0.0090). Eight eyes initiated or continued IOP lowering medications.ConclusionsThese data suggest the 0.2??g/day FAc implant is effective in vitrectomized patients with an acceptable safety profile. Further studies are still required to confirm the current findings and to assess the effect of the 0.2??g/day FAc implant over a longer period of follow-up.

SUBMITTER: Meireles A

PROVIDER: S-EPMC5437318 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Efficacy of 0.2 μg/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy.

Meireles A A Goldsmith C C El-Ghrably I I Erginay A A Habib M M Pessoa B B Coelho J J Patel T T Tadayoni R R Massin P P Atorf J J Augustin A J AJ

Eye (London, England) 20170113 5

PurposeLimited data are available on the efficacy of the 0.2 μg/day fluocinolone acetonide (FAc) implant in eyes with prior vitrectomy. Here, we present a collection of 26 vitrectomized eyes treated with the 0.2 μg/day FAc implant.MethodsRetrospective study involving six centers from four European countries analyzing the safety and efficacy data from patients (26 eyes from 25 patients) with DME and a prior vitrectomy that had been treated with one 0.2 μg/day FAc implant.ResultsPrior intravitreal ...[more]

PMID: 28085139

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Project description:ObjectiveTo examine the long-term efficacy and safety of the intravitreal 0.2-μg/day fluocinolone acetonide implant (FAi) to treat noninfectious uveitis (NIU) of the posterior segment (PS).DesignThree-year, phase III, multicenter, randomized, double-masked, controlled, prospective study (clinicaltrials.gov, NCT02746991).ParticipantsOverall, 153 patients in India with NIU-PS in ≥ 1 eye (with or without anterior uveitis) for ≥ 1 year who had ≥ 2 separate recurrences of uveitis requiring ocular injections or systemic therapy in the prior 12 months.MethodsPatients were randomized 2:1 for baseline FAi or sham injection and monitored for main outcome measures.Main outcome measuresIncidence and timing of uveitis recurrence, use of adjunctive therapy, best-corrected visual acuity, central foveal thickness, and monitoring of intraocular pressure (IOP)- and cataract-related events over 36 months.ResultsOverall, 153 patients (FAi, n = 101; treated sham, n = 52) were enrolled. Fluocinolone acetonide implant-treated eyes had significantly reduced uveitis recurrence rates versus treated sham (46.5% vs. 75.0%, respectively; P = 0.001) and a longer median time to recurrence (1116.0 [95% confidence interval, 847.00 to not evaluable] vs. 190.5 [95% confidence interval, 100.0-395.0] days for treated sham). Systemic adjunctive treatments were similar between groups, but fewer FAi-treated eyes required adjunctive injections (8.9% vs. 51.9% for treated sham). Visual outcomes were similar between groups, and residual macular edema was more common at 36 months in treated sham versus FAi-treated eyes (46.2% vs. 24.2%, respectively). The FAi-treated group had a lower central foveal thickness from month 12 onward. Intraocular pressure-lowering surgeries were stable in both groups, but, as expected, rates of IOP elevations were more frequent in the FAi-treated group than in the treated sham (IOP > 25 mmHg: 23.8% vs. 3.8%; IOP > 30 mmHg: 16.8% vs. 1.9%, respectively), and FAi-treated eyes had a higher incidence of cataract surgery than the treated sham (70.5% vs. 26.5%, respectively).ConclusionsIn patients with NIU-PS, the 0.2-μg/day FAi is associated with reduced-uveitis recurrence and increased time to first recurrence while controlling macular edema, maintaining stable IOP levels, and providing an expected safety profile, including a higher occurrence of cataract formation over 36 months.Financial disclosuresThe authors have no proprietary or commercial interest in any materials discussed in this article.

Project description:BackgroundDiabetic macular oedema (DMO) may lead to visual loss and blindness. Several pharmacological treatments are available on the National Health Service (NHS) to United Kingdom patients affected by this condition, including intravitreal vascular endothelial growth factor inhibitors (anti-VEGFs) and two types of intravitreal steroid implants, releasing dexamethasone or fluocinolone acetonide (FAc). This study aimed to assess the value for money (cost-effectiveness) of the FAc 0.2??g/day implant (ILUVIEN®) in patients with chronic DMO considered insufficiently responsive to other therapies.MethodsWe developed a Markov model with a 15-year time horizon to estimate the impact of changes in best-corrected visual acuity in DMO patients on costs and quality-adjusted life years. The model considered both eyes, designated as the "study eye", defined at model entry as phakic with an ongoing cataract formation or pseudophakic, and the "fellow eye". The model compared the FAc 0.2??g/day implant with a 700??g dexamethasone implant (pseudophakic patients only) or with usual care, defined as a mixture of laser photocoagulation and anti-VEGFs (phakic and pseudophakic patients). Costs were estimated from the perspective of the NHS and Personal Social Services; full NHS prices were used for drugs.ResultsIn patients who were pseudophakic at baseline, at 36?months, the FAc implant provided an additional gain of 4.01 and 3.64 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with usual care and the dexamethasone implant, respectively. Over the 15-year time horizon, this translated into 0.185 additional quality-adjusted life years (QALYs) at an extra cost of £3066 compared with usual care, and 0.126 additional QALYs at an extra cost of £1777 compared with dexamethasone. Thus, incremental cost-effectiveness ratios (ICERs) were £16,609 and £14,070 per QALY gained vs. usual care and dexamethasone, respectively. In patients who were phakic at baseline, the FAc 0.2??g/day implant provided an additional gain of 2.96 ETDRS letters at 36?months compared with usual care, which, over 15?years, corresponded to 0.11 additional QALYs at an extra cost of £3170, resulting in an ICER of £28,751 per QALY gained.ConclusionThe FAc 0.2??g/day implant provided good value for money compared with other established treatments, especially in pseudophakic patients.

Dataset Information

Efficacy of 0.2??g/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy.

Publications

Efficacy of 0.2 μg/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy.

Similar Datasets

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