An overview of the clinical outcomes of the fluocinolone acetonide 190 µg intravitreal implant clinical evidence study in the United Kingdom (ICE-UK)

Peto, Tunde

doi:10.1080/03007995.2017.1376453

Cited by 3 publications

(16 citation statements)

References 12 publications

(18 reference statements)

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“…The FAc intravitreal implant has been licensed in 17 European countries for the management of chronic DME when other treatments have proven to be insufficiently effective. 20 The present report supports other real-world studies, 8,17 which have shown that patients treated with FAc implant typically have a more chronic DME presentation and more prior therapies than in those in clinical trials. In Europe, the use of the FAc implant is indicated as a second-line therapy and mainly after a sub-optimal response to prior treatment with an anti-VEGF agent.…”

Section: Discussion/conclusionsupporting

confidence: 89%

“…20 Supplemental treatment for patients in Portugal tended to be macular laser therapy, whereas in the United Kingdom it was most frequently anti-VEGF therapy. 20 In both countries, anti-VEGF therapy is currently considered the gold standard and the first-line treatment for DME. 20 Differences in DME treatment prior to FAc implant administration in ICE-UK and ICE-PT may be explained by variations in therapy recommendations between the United Kingdom and Portugal.…”

Section: Discussion/conclusionmentioning

confidence: 99%

“…In the United Kingdom, most patients received anti-VEGF (82% of patients) and macular laser therapy (63% of patients) prior to FAc implant administration. 20 In Portugal, patients receive a mean of 2.2 anti-VEGF and 1.4 corticosteroid injections prior to FAc implant administration. In the United Kingdom, a large proportion of patients had received >6 prior DME treatments at FAc implant administration.…”

Section: Discussion/conclusionmentioning

confidence: 99%

“…In the United Kingdom, a large proportion of patients had received >6 prior DME treatments at FAc implant administration. 20 Supplemental treatment for patients in Portugal tended to be macular laser therapy, whereas in the United Kingdom it was most frequently anti-VEGF therapy. 20 In both countries, anti-VEGF therapy is currently considered the gold standard and the first-line treatment for DME.…”

Section: Discussion/conclusionmentioning

confidence: 99%

“…20 In both countries, anti-VEGF therapy is currently considered the gold standard and the first-line treatment for DME. 20 Differences in DME treatment prior to FAc implant administration in ICE-UK and ICE-PT may be explained by variations in therapy recommendations between the United Kingdom and Portugal. In the United Kingdom, FAc intravitreal implant administration is indicated for treating chronic DME that is insufficiently responsive to available therapies in eyes with a pseudophakic lens, provided that the manufacturer provides the FAc implant with the discount agreed in the patient access scheme.…”

Section: Discussion/conclusionmentioning

confidence: 99%

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Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN^® clinical evidence study in Portugal

et al. 2020

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Introduction: The ILUVIEN® (fluocinolone acetonide) Clinical Evidence in Portugal (ICE-PT) study is a retrospective, multicenter, observational study evaluating the effectiveness and safety of the FAc implant in patients with diabetic macular edema. Methods: Patients included in this study had received the 0.2 µg/day fluocinolone acetonide implant for the treatment of diabetic macular edema and had measurements of visual acuity and retinal thickness assessed by optical coherence tomography for at least 12 months pre- and post-fluocinolone acetonide implant administration, with ⩾2 follow-up visits. Outcomes measured included visual acuity, central foveal thickness, and intraocular pressure. Results: There was a significant increase in mean visual acuity compared with baseline at 3, 6, 9, and 12 months post-fluocinolone acetonide in both the overall study population and the pseudophakic subgroup ( p < 0.05 at all time points in both groups). A significant reduction in mean central foveal thickness compared with baseline was seen in the overall study population at 3, 6, 9, and 12 months post-fluocinolone acetonide ( p < 0.05 at all time points). At 12-month post-fluocinolone acetonide, a small but significant intraocular pressure increase of 1.0 mmHg was seen in the overall study population. Conclusion: The results of this analysis show that switching from the current standard of care to the fluocinolone acetonide implant leads to beneficial effects in terms of vision and retinal structure in patients with diabetic macular edema and that patients benefited from FAc implant administration, regardless of lens status.

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Section: Discussion/conclusionsupporting

confidence: 89%

Section: Discussion/conclusionmentioning

confidence: 99%

Section: Discussion/conclusionmentioning

confidence: 99%

Section: Discussion/conclusionmentioning

confidence: 99%

Section: Discussion/conclusionmentioning

confidence: 99%

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Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN^® clinical evidence study in Portugal

et al. 2020

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The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

Salvetat,

Pellegrini,

Spadea

et al. 2024

JCM

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Diabetic macular edema (DME) is a common complication of diabetes mellitus and a leading cause of visual impairment worldwide. It is defined as the diabetes-related accumulation of fluid, proteins, and lipids, with retinal thickening, within the macular area. DME affects a significant proportion of individuals with diabetes, with the prevalence increasing with disease duration and severity. It is estimated that approximately 25–30% of diabetic patients will develop DME during their lifetime. Poor glycemic control, hypertension, hyperlipidemia, diabetes duration, and genetic predisposition are recognized as risk factors for the development and progression of DME. Although the exact pathophysiology is still not completely understood, it has been demonstrated that chronic hyperglycemia triggers a cascade of biochemical processes, including increased oxidative stress, inflammation, activation of vascular endothelial growth factor (VEGF), cellular dysfunction, and apoptosis, with breakdown of the blood-retinal barriers and fluid accumulation within the macular area. Early diagnosis and appropriate management of DME are crucial for improving visual outcomes. Although the control of systemic risk factors still remains the most important strategy in DME treatment, intravitreal pharmacotherapy with anti-VEGF molecules or steroids is currently considered the first-line approach in DME patients, whereas macular laser photocoagulation and pars plana vitrectomy may be useful in selected cases. Available intravitreal steroids, including triamcinolone acetonide injections and dexamethasone and fluocinolone acetonide implants, exert their therapeutic effect by reducing inflammation, inhibiting VEGF expression, stabilizing the blood-retinal barrier and thus reducing vascular permeability. They have been demonstrated to be effective in reducing macular edema and improving visual outcomes in DME patients but are associated with a high risk of intraocular pressure elevation and cataract development, so their use requires an accurate patient selection. This manuscript aims to provide a comprehensive overview of the pathology, epidemiology, risk factors, physiopathology, clinical features, treatment mechanisms of actions, treatment options, prognosis, and ongoing clinical studies related to the treatment of DME, with particular consideration of intravitreal steroids therapy.

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Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant

et al. 2022

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To assess anatomical and functional outcomes after switching from dexamethasone implant (DEXi) to fluocinolone acetonide implant (FAci) in 113 diabetic macular edema eyes, a multicentric retrospective observational study was conducted. Seventy-five eyes (73.5%) were switched 1–8 weeks after their last DEXi. The mean best-corrected visual acuity improved to 59.8 letters at month 4 and remained stable during the follow-up. The mean central macular thickness (CMT) significantly decreased during the follow-up, with a minimum of 320.9 μm at month 3. The baseline CMT was higher in eyes that received the last DEXi >8 weeks versus <8 weeks before the first FAci (p < 0.021). After FAci injection, additional treatments were needed in 37 (32.7%) eyes. A longer diabetes duration (p = 0.009), a longer time between the last DEXi and the first FAci (p = 0.035), and a high baseline CMT (p = 0.003) were risk factors for additional treatments. The mean intraocular pressure was <19 mmHg at all timepoints, with no difference between eyes receiving the last DEXi ≤8 weeks or >8 weeks before the switch. Switching from DEXi to FAci in DME is effective and safe. A short time between the last DEXi and the first FAci reduced CMT fluctuations and the need for early additional treatments.

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An overview of the clinical outcomes of the fluocinolone acetonide 190 µg intravitreal implant clinical evidence study in the United Kingdom (ICE-UK)

Cited by 3 publications

References 12 publications

Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN^® clinical evidence study in Portugal

Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN^® clinical evidence study in Portugal

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant

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An overview of the clinical outcomes of the fluocinolone acetonide 190 µg intravitreal implant clinical evidence study in the United Kingdom (ICE-UK)

Cited by 3 publications

References 12 publications

Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN® clinical evidence study in Portugal

Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN® clinical evidence study in Portugal

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant

Contact Info

Product

Resources

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Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN^® clinical evidence study in Portugal

Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN^® clinical evidence study in Portugal