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.

scholarly journals Real-world management and long-term outcomes of diabetic macular oedema with good visual acuity

Eye ◽  
2019 ◽  
Vol 34 (6) ◽  
pp. 1108-1115
Author(s):  
Kieu-Yen Luu ◽  
Mutaal M. Akhter ◽  
Blythe P. Durbin-Johnson ◽  
Ala Moshiri ◽  
Steven Tran ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Real World ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Long Term Outcomes ◽  
Good Visual Acuity

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.

scholarly journals Dexamethasone intravitreal implant in treatment-naïve diabetic macular oedema: findings from the prospective, multicentre, AUSSIEDEX study

2021 ◽  
pp. bjophthalmol-2021-319070
Author(s):  
Samantha Fraser-Bell ◽  
Hyong Kwon Kang ◽  
Paul Mitchell ◽  
Jennifer J Arnold ◽  
Jodi Tainton ◽  
...  
Keyword(s):  
Real World ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Common Adverse Event ◽  
Open Label ◽  
Dexamethasone Intravitreal Implant ◽  
Intravitreal Implant ◽  
Registration Number ◽  
Treatment Naïve ◽  
Change In Mean

AimTo evaluate the effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX; Ozurdex) monotherapy in the patient subgroup of the AUSSIEDEX study with treatment-naïve diabetic macular oedema (DME).MethodsThe open-label, prospective, phase 4, real-world study included pseudophakic eyes and phakic eyes scheduled for cataract surgery that were treatment-naïve or non-responsive to antivascular endothelial growth factors. No eyes were excluded based on baseline best-corrected visual acuity (BCVA) or central subfield retinal thickness (CRT). After the initial DEX injection at the baseline visit, reinjection was permitted at ≥16-week intervals. Week-16 and week-52 visits were mandatory. Primary endpoints were changes in mean BCVA and CRT from baseline to 52 weeks.ResultsOf 200 eyes enrolled in the AUSSIEDEX study, 57 were treatment-naïve. Baseline mean BCVA was 58.8 letters and baseline mean CRT was 418.6 µm; changes in mean BCVA and CRT from baseline to 52 weeks in this subgroup were 3.4 letters (p=0.042) and –89.6 µm (p<0.001), respectively, with a mean 2.5 injections. The change in mean CRT from baseline was –55.8 µm at week 16 (p<0.001). The most common adverse event was increased intraocular pressure (IOP), with 20.0% of eyes requiring IOP-lowering medication. One patient was discontinued due to increased IOP. No eyes required filtration surgery. No serious, treatment-related ocular adverse events were reported.ConclusionIn this largest prospective, real-world study of DEX monotherapy for DME to date, DEX significantly improved CRT and BCVA at 52 weeks in treatment-naïve eyes, without new safety concerns, supporting DEX use in treatment-naïve DME.Trial registration numberNCT02731911.

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