scholarly journals Correction: The outcome of fluocinolone acetonide intravitreal implant is predicted by the response to dexamethasone implant in diabetic macular oedema

Eye ◽  
2021 ◽  
Author(s):  
Maria Vittoria Cicinelli ◽  
◽  
Amir Rosenblatt ◽  
Domenico Grosso ◽  
Piero Zollet ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Dexamethasone Implant ◽  
Intravitreal Implant ◽  
Fluocinolone Acetonide Intravitreal Implant

scholarly journals Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study

2020 ◽  
pp. bjophthalmol-2020-315984
Author(s):  
Sam E Mansour ◽  
Daniel F Kiernan ◽  
Daniel B Roth ◽  
David Eichenbaum ◽  
Nancy M Holekamp ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Oedema ◽  
Prospective Observational Study ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Central Subfield Thickness ◽  
Intravitreal Implant ◽  
Registration Number ◽  
Fluocinolone Acetonide Intravitreal Implant

BackgroundThe 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, ‘real-world’ safety results for the FAc implant in DMO.MethodsThis 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured.ResultsData were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1–3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 µm was significantly increased (p=0.041).ConclusionFew IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit–risk profile in the management of DMO, especially when administered after a prior steroid challenge.Trial registration numberNCT02424019.

The long-term efficacy and safety of fluocinolone acetonide intravitreal implant 190 μg (ILUVIEN®) in diabetic macular oedema in a multi-ethnic inner-city population

2020 ◽  
pp. 112067211989841 ◽  
Author(s):  
Georgios D Panos ◽  
Natalia Arruti ◽  
Sudeshna Patra
Keyword(s):  
Macular Oedema ◽  
Retinal Thickness ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Corrected Visual Acuity ◽  
Intravitreal Implant ◽  
Minority Ethnic ◽  
Fluocinolone Acetonide Intravitreal Implant

Purpose: The purpose of this study is to report the long-term efficacy and safety of 0.19 mg fluocinolone acetonide intravitreal implant (ILUVIEN®) in pseudophakic eyes with diabetic macular oedema in a multi-ethnic patient cohort. Methods: This is a single-centre retrospective analysis of patients with persistent diabetic macular oedema, despite previous anti-vascular endothelial growth factor and/or steroid treatment, treated with the ILUVIEN implant according to national guidelines. Patients with follow-up of less than 24 months were excluded. Best corrected visual acuity, central retinal thickness and intraocular pressure were evaluated at baseline and month 3, 12, 24 and 36 post-treatment. A sub-group analysis was performed on eyes with 36-month follow-up data. Results: In total, 24 eyes (24 patients) completed at least 24 months of follow-up, of which 9 completed 36 months of follow-up. Three-fourths of the patients were black or South Asian (blacks, Asians and minority ethnic). Improvement in mean best corrected visual acuity was seen at year 1 and year 3 improving from 0.62 LogMAR at baseline to 0.55 LogMAR at year 1 and 0.47 LogMAR at year 3 (all p > 0.05). Mean central retinal thickness also showed a progressive reduction from 471 μm at baseline to 397 μm at year 1 and 339 μm at year 3 (all p < 0.05). Four eyes required intraocular pressure–lowering drops post-implant. Supplementary treatment for persistent or recurrent diabetic macular oedema was necessary in 13 eyes over the total study period of 3 years. Blacks, Asians and minority ethnic patients had a worse response compared with white patients. Conclusion: The ILUVIEN implant was effective and safe in the treatment of multi-ethnic patients with diabetic macular oedema refractory to conventional therapies, improving the vision and macular anatomy, without significant adverse events up to 36 months post-treatment.

The Treatment of Diabetic Macular Oedema with ILUVIEN® Intravitreal Implant Following Prior Anti-VEGF Therapy – Case Study

2014 ◽  
Vol 08 (02) ◽  
pp. 140
Author(s):  
Fahd Quhill ◽  
Keyword(s):  
Macular Oedema ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Vascular Endothelial ◽  
Foveal Thickness ◽  
Intravitreal Implant ◽  
The Uk ◽  
Endothelial Growth Factor

Diabetic macular oedema (DMO) is the main cause of vision loss in diabetic retinopathy. The ILUVIEN® intravitreal implant, which contains fluocinolone acetonide and is administered by injection into the vitreous cavity, should be considered if the patient is not responding to anti-vascular endothelial growth factor (VEGF) therapy, and the patient fulfils the recommendations of the National Institute for Health and Care Excellence (NICE) Technology Appraisal 301. The efficacy and safety of the ILUVIEN implant has been demonstrated in clinical studies, and a pre-planned subgroup analysis has shown that it is particularly beneficial in patients with chronic DMO. This case study is the first report in the UK of the effectiveness of the ILUVIEN implant in a patient in whom therapy with ranibizumab did not result in sustained improvements in terms of visual outcomes and foveal thickness.

Real-world Experience of Fluocinolone Acetonide (0.2 μg/day) Intravitreal Implant in the Treatment of Diabetic Macular Oedema

2015 ◽  
Vol 09 (01) ◽  
pp. 42 ◽  
Author(s):  
Fahd Quhill ◽  
Keyword(s):  
Real World ◽  
Macular Oedema ◽  
Clinical Studies ◽  
Case Reports ◽  
Case Series ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Functional Benefit ◽  
Intravitreal Implant ◽  
The Impact

Fluocinolone acetonide intravitreal implant (ILUVIENR, FAc intravitreal implant) is approved for clinical use in Europe and US for the treatment of diabetic macular oedema (DMO). In Europe, the implant is indicated for chronic DMO patients who are insufficiently responsive to available therapies. The use of FAc intravitreal implants has been shown to be effective in pivotal clinical trial studies. Case reports and case series of FAc intravitreal implants in chronic DMO are now emerging and combined analysis of these reveals interesting findings that complement the findings in the clinical studies. Visual improvement and central retinal thickness reductions are similar to those of the clinical trials, which is surprising given that treatments often perform less well in the real-world. In addition, the incidence of intraocular pressure (IOP) elevations is lower than reported in the clinical studies. However, further follow-up is ongoing and this needs to be confirmed in a larger population of subjects. This article reviews some of these important real-world data and their likely impact on future chronic DMO treatment practice as well as the impact in terms of the functional benefit to patients with impaired vision.

Intravitreal ILUVIEN® Implant for Diabetic Macular Oedema – Early Case Experiences

2013 ◽  
Vol 07 (02) ◽  
pp. 122 ◽  
Author(s):  
Thomas Bertelmann ◽  
Anke Messerschmidt-Roth ◽  
◽  
Keyword(s):  
Macular Oedema ◽  
Vision Loss ◽  
Treatment Options ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Comprehensive Treatment ◽  
Vascular Endothelial ◽  
Intravitreal Implant ◽  
Early Case ◽  
Endothelial Growth Factor

Diabetic macular oedema (DMO) is an important cause of vision loss and challenges remain in the treatment of this progressive disease. Corticosteroids provide a comprehensive treatment approach, lowering the concentration of inflammatory cytokines and growth factors such as vascular endothelial growth factor (VEGF). However, intravitreal injections are often short-lived and are associated with intraocular side effects. The ILUVIEN® intravitreal implant contains fluocinolone acetonide and is administered by injection into the vitreous cavity. Its efficacy and safety have been demonstrated in clinical studies, and a subgroup analysis has shown that it is particularly beneficial in patients with long-standing DMO – a group with poor visual outcomes and limited treatment options. As a result, the ILUVIEN implant has been approved in Europe for the treatment of visual impairment due to chronic DMO considered insufficiently responsive to available therapies. These data have been supported by real-use clinical experience and two cases are presented that demonstrate the effectiveness of the ILUVIEN implant in two patients where prior therapies including ranibizumab have not produced a sustained beneficial effect.

Management of Diabetic Macular Oedema – Challenges and Solutions Along the Patient Journey

2013 ◽  
Vol 07 (02) ◽  
pp. 115
Author(s):  
Albert J Augustin ◽  
Sue Lightman ◽  
Anat Loewenstein ◽  
José Cunha-Vaz
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Clinical Trial Data ◽  
Fluocinolone Acetonide ◽  
Patient Journey ◽  
Anti Vegf ◽  
Long Duration ◽  
Intravitreal Implant ◽  
Disease Stages ◽  
Endothelial Growth Factor

A symposium hosted by the European Society of Ophthalmology discussed challenges in the management of diabetic macular oedema (DMO). Clinical evidence suggests that the longer the duration of DMO, the worse the response to anti-vascular endothelial growth factor (anti-VEGF) agents and better the response to corticosteroids. This is explained by the fact that inflammation is involved in the perpetuation of retinal changes in diabetes. At early disease stages, VEGF is primarily responsible for retinal changes; however, chronic microglia activation resulting from retinal damage leads to cytokine production by retinal cells and subsequent inflammatory cascades. Steroids are most effective at this stage. Clinical trial data have demonstrated the efficacy of the Iluvien® fluocinolone acetonide (FA) intravitreal implant, which retains its efficacy in disease of long duration. However, it is important to remember two things: that diabetes is a multifactorial disease with potential complications and to monitor for safety effects. In terms of the latter, anti-VEGF agents are associated with potential systemic effects, whereas steroids raise intraocular pressure and are associated with increased incidence of cataract.

scholarly journals The 0.19 mg Fluocinolone Acetonide Intravitreal Implant – A Review on its Use in Diabetic Macular Oedema from the Association for Research in Vision and Ophthalmology Annual Meeting 2018

2018 ◽  
Vol 12 (2) ◽  
pp. 88
Author(s):  
Anat Loewenstein ◽  
Usha Chakravarthy ◽  
Francesco Bandello ◽  
◽  
◽  
...  
Keyword(s):  
Annual Meeting ◽  
Real World ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Fluocinolone Acetonide ◽  
Similar Time ◽  
Intravitreal Implant ◽  
Time Point

Diabetic macular oedema (DMO) is a complication of diabetic retinopathy and a leading cause of visual impairment in patients with diabetes. ILUVIEN® (Alimera Sciences Inc., Alpharetta, GA, USA) is an intravitreal implant of fluocinolone acetonide (FAc), which is indicated in Europe for the treatment of vision impairment associated with chronic DMO that is considered insufficiently responsive to available therapies. This article reviews the clinical effectiveness and safety of the FAc implant from real-world studies presented at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting. Review findings: Evidence from real-world studies, with the FAc implant in persistent or recurrent DMO, show consistent outcomes at a similar time point with those reported in the pivotal randomised controlled trials (RCTs). Real-world studies have also shown that the FAc implant led to improvements in visual acuity and central retinal thickness, as well as reductions in treatment burden. Increases in intraocular pressure (IOP) observed in these studies were consistent with those reported at a similar time point in the RCTs and with the effect of other corticosteroid treatments. Expert opinion and conclusions: The results suggest that FAc offers a clinical and cost-effective alternative in the treatment of persistent or recurrent DMO. There are low risks of raised IOP and cataract formation, both of which are amenable to treatment.

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