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.

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 Intravitreal fluocinolone acetonide implant (ILUVIEN®) for diabetic macular oedema: a literature review

2018 ◽  
Vol 47 (1) ◽  
pp. 31-43 ◽  
Author(s):  
Horace Massa ◽  
Anindyt M. Nagar ◽  
Athanasios Vergados ◽  
Panagiotis Dadoukis ◽  
Sudeshna Patra ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Laser Photocoagulation ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Vascular Endothelial ◽  
Common Complication ◽  
Severe Visual Loss ◽  
Fluocinolone Acetonide Implant ◽  
Endothelial Growth Factor ◽  
Review Current

Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy and may lead to severe visual loss. In this review, we describe the pathophysiology of DMO and review current therapeutic options such as macular laser photocoagulation, anti-vascular endothelial growth factor agents, and steroid implants with a focus on the new fluocinolone acetonide implant, ILUVIEN®. The results of the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) studies are also presented together with the results of real-world studies to support the clinical use of ILUVIEN® in achieving efficient resolution of DMO and improving vision and macular anatomy in this challenging group of patients.

scholarly journals Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema

2014 ◽  
Vol 08 (01) ◽  
pp. 67
Author(s):  
Marco Dutra Medeiros ◽  
Micol Alkabes ◽  
Paolo Nucci ◽  
◽  
◽  
...  
Keyword(s):  
Macular Oedema ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Dexamethasone Intravitreal Implant ◽  
Novel Approach ◽  
Intravitreal Implant ◽  
Working Age ◽  
Infectious Uveitis ◽  
Corticosteroid Drugs ◽  
Endothelial Growth Factor

Diabetic macular oedema (DMO) is a leading cause of vision loss in the working-age population worldwide. Corticosteroid drugs have been demonstrated to inhibit the expression of both the vascular endothelial growth factor (VEGF) gene and other anti-inflammatory mediators, such as prostaglandins. Triamcinolone, fluocinolone and dexamethasone are the main steroids that have been studied for the treatment of macular oedema. Over the last few years, several studies have suggested an important role for dexamethasone in the management of DMO. The dexamethasone intravitreal implant (DEX implant) (Ozurdex®; Allergan, Inc., Irvine, CA) is a novel approach approved by the US Food and Drug Administration (FDA) and by the EU for the intravitreal treatment of macular oedema after branch or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye. We reviewed manuscripts that had investigated the pharmacokinetics, efficacy and safety of the DEX implant regarding DMO treatment.

Managing Insufficiently Responsive DMO Patients Post-NICE Guidance

2014 ◽  
Vol 08 (01) ◽  
pp. 61
Author(s):  
Usha Chakravarthy ◽  
Louise Downey ◽  
Baruch D Kuppermann ◽  
Rupert Bourne ◽  
Robin Hamilton ◽  
...  
Keyword(s):  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Phase Iii Clinical Trials ◽  
Clinical Scenarios ◽  
Intravitreal Implant ◽  
Nice Guidance ◽  
Retinal Inflammation ◽  
Endothelial Growth Factor

A satellite symposium, chaired by Usha Chakravarthy, was held at the Royal College of Ophthalmologists Annual Congress in Birmingham, entitled Managing Insufficiently Responsive DMO Patients Post-NICE Guidance. While therapies targeting vascular endothelial growth factor (VEGF), such as ranibizumab, have proven benefit in the treatment of diabetic macular oedema (DMO), patients with disease of longer duration may not respond as well to these therapies, a result of the more complex pathophysiology of chronic DMO, involving retinal inflammation. Corticosteroids offer a multi-factorial treatment approach, acting on numerous biochemical and anatomical pathways, unlike ranibizumab and bevacizumab, which inhibit VEGF and consequently confer their benefits through the modification of a single pathway. The ILUVIEN® intravitreal implant, contains 190 μg of fluocinolone acetonide (FAc), with an average release rate of 0.2 μg/ day for up to 36 months. Its benefits are most pronounced in patients with chronic DMO. ILUVIEN is indicated for the treatment of vision impairment associated with chronic DMO, considered insufficiently responsive to available therapies. The effectiveness of ILUVIEN was demonstrated in phase III clinical trials, and these benefits are being replicated in routine clinical practice. In this symposium, the speakers described clinical scenarios that demonstrated the utility of ILUVIEN in patients with DMO that are insufficiently responsive to currently available first-line therapies.

scholarly journals Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema

2014 ◽  
Vol 10 (2) ◽  
pp. 111 ◽  
Author(s):  
Marco Dutra Medeiros ◽  
Micol Alkabes ◽  
Paolo Nucci ◽  
◽  
◽  
...  
Keyword(s):  
Macular Oedema ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Dexamethasone Intravitreal Implant ◽  
Novel Approach ◽  
Intravitreal Implant ◽  
Working Age ◽  
Infectious Uveitis ◽  
Corticosteroid Drugs ◽  
Endothelial Growth Factor

Diabetic macular oedema (DMO) is a leading cause of vision loss in the working-age population worldwide. Corticosteroid drugs have been demonstrated to inhibit the expression of both the vascular endothelial growth factor (VEGF) gene and other anti-inflammatory mediators, such as prostaglandins. Triamcinolone, fluocinolone and dexamethasone are the main steroids that have been studied for the treatment of macular oedema. Over the last few years, several studies have suggested an important role for dexamethasone in the management of DMO. The dexamethasone intravitreal implant (DEX implant) (Ozurdex®; Allergan, Inc., Irvine, CA) is a novel approach approved by the US Food and Drug Administration (FDA) and by the EU for the intravitreal treatment of macular oedema after branch or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye. We reviewed manuscripts that had investigated the pharmacokinetics, efficacy and safety of the DEX implant regarding DMO treatment.

scholarly journals Intravitreal Ranibizumab for Diabetic Macular Oedema

2015 ◽  
Vol 09 (01) ◽  
pp. 32 ◽  
Author(s):  
Francesco Bandello ◽  
Maria Vittoria Cicinelli ◽  
Maurizio Battaglia Parodi ◽  
◽  
◽  
...  
Keyword(s):  
Macular Oedema ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Vascular Endothelial ◽  
Intravitreal Ranibizumab ◽  
Remarkable Effect ◽  
The Past ◽  
Endothelial Growth Factor ◽  
Ranibizumab Treatment

Diabetic macular oedema (DMO) is the most frequent cause of vision loss in patients affected by diabetes mellitus, and has a remarkable effect on public health. The treatment with focal/grid laser photocoagulation was considered in the past decades as the standard of care, but the recent advent of new pharmacological approaches, based on the use of intravitreal anti-vascular endothelial growth factor (anti-VEGF), has completely revolutionised the management of DMO. The most important molecule of this class of drugs is represented by ranibizumab, which has been clinically supported by several randomised clinical trials. The present review aims at providing a comprehensive summary of the most important investigations regarding the ranibizumab treatment of DMO.

scholarly journals Evidence for Anti-vascular Endothelial Growth Factor Treatment of Diabetic Macular Oedema

2010 ◽  
Vol 8 (1) ◽  
pp. 36 ◽  
Author(s):  
Francesco Bandello ◽  
Umberto De Benedetto ◽  
Karl Anders Knutsson ◽  
Maurizio Battaglia Parodi ◽  
Maria Lucia Cascavilla ◽  
...  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Macular Oedema ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Standard Of Care ◽  
Vascular Endothelial ◽  
Cell Mitogen ◽  
Endothelial Growth Factor

Diabetic macular oedema (DME) represents the most common cause of vision loss in patients affected by diabetes mellitus. Diabetic retinopathy has a significant impact on public health and the quality of life of many patients and thus requires serious consideration. The first line of treatment remains the management of systemic risk factors but this is often insufficient in controlling DME and currently, laser retinal photocoagulation is considered the standard of care. However, laser treatment reduces the risk of moderate visual loss by approximately 50 % without guaranteeing remarkable effects on visual improvement. For these reasons, new approaches in the treatment of DME have been considered, in particular the employment of anti-vascular endothelial growth factor (VEGF) drugs. VEGF is a pluripotent growth factor that functions as a vasopermeability factor and an endothelial cell mitogen and thereby represents an appealing candidate as a therapeutic target for the treatment of DME. The goal of this article is to present the evidence behind the use of anti-VEGF drugs in the treatment of DME.

scholarly journals Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

Eye ◽  
2021 ◽  
Author(s):  
Clare Bailey ◽  
◽  
Usha Chakravarthy ◽  
Andrew Lotery ◽  
Geeta Menon ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Clinical Effectiveness ◽  
Fluocinolone Acetonide ◽  
Prior History ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Laser Trabeculoplasty ◽  
Retrospective Audit ◽  
History Of

Abstract Background This study aimed to assess the long-term effectiveness of the 0.2 μg/day fluocinolone acetonide (FAc) implant over ≥3 years for patients with diabetic macular oedema. Methods A retrospective audit of pseudo-anonymised data from patients with chronic diabetic macular oedema (cDMO) and treated with the FAc implant across 14 UK clinical sites. Safety and clinical effectiveness were measured. Results Two-hundred and fifty-six eyes had ≥3 years of follow-up (mean 4.28 years), during which a mean of 1.14 FAc implants were used per eye. Mean best-recorded visual acuity (BRVA) increased from 52.6 to 56.7 letters at month 3 and remained stable thereafter; this trend was also seen in pseudophakic eyes. The proportion of patients attaining a BRVA ≥6/12 increased from 17% at baseline to 27% 1 month after FAc implant and remained stable above 30% from month 12 onwards. Eyes with no prior history of intraocular pressure (IOP)-related events required significantly less treatment-emergent IOP-lowering medication than those with a prior history of IOP events (17.9% vs. 50.0% of eyes; p < 0.001). The incidence of an IOP increase of ≥10 mmHg, use of IOP-lowering medication, laser trabeculoplasty and IOP-lowering surgery was 28.9%, 29.7%, 0.8% and 2.7%, respectively, for the whole cohort. There were significant reductions in mean central foveal thickness and macular volume (p < 0.001). Conclusions The FAc implant was well tolerated, with predictable and manageable IOP-related events while delivering a continuous microdose of corticosteroid to eyes with cDMO, providing prolonged vision preservation and a reduced number of treatments.

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