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.

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.

scholarly journals The role of future treatments in the management of neovascular age-related macular degeneration in Europe

2021 ◽  
pp. 112067212110183
Author(s):  
Laurent Kodjikian ◽  
Carl Joe Mehanna ◽  
Salomon-Yves Cohen ◽  
François Devin ◽  
Sam Razavi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Real World Data ◽  
Phase Iii Clinical Trials ◽  
Age Related ◽  
Injection Frequency ◽  
Endothelial Growth Factor

Anti-vascular endothelial growth factor (VEGF) agents have transformed the management of patients with neovascular age-related macular degeneration (nAMD) over the past two decades. However, as more long-term real-world data become available, it is clear that treatment outcomes are inferior to those reported in large, controlled clinical trials. This is largely driven by undertreatment, that is, not maintaining a consistent injection frequency to achieve sustained VEGF suppression, whether due to patient non-compliance, an important injection burden, or non/incomplete anatomical response. Newer therapeutic advances under evaluation hold promise in achieving more, for less. We review the latest drugs currently in or having successfully finished phase III clinical trials, and determine their potential place in the management of patients with nAMD in Europe.

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.

The impact of vitrectomy on outcomes achieved with 0.19 mg fluocinolone acetonide implant in patients with diabetic macular edema

2021 ◽  
pp. 112067212110147
Author(s):  
Albert J Augustin ◽  
Silvia Bopp ◽  
Martin Fechner ◽  
Frank G Holz ◽  
Dirk Sandner ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Disease Process ◽  
Fluocinolone Acetonide ◽  
Vascular Endothelial ◽  
First Line ◽  
Intravitreal Implant ◽  
Fluocinolone Acetonide Implant ◽  
Endothelial Growth Factor ◽  
The Impact

Background: There is a lack of consensus on the use of intravitreal corticosteroid therapies in patients with diabetic macular edema (DME) and prior vitrectomized eyes in clinical practice. Methods: Retro-IDEAL was a 3-year retrospective, multicenter study in patients with chronic DME (i.e. DME that persists or recurs despite treatment) treated with ILUVIEN® (0.2 µg daily fluocinolone acetonide intravitreal implant), who had suboptimal outcomes with first-line vascular endothelial growth-factor inhibitors and other DME therapies. Results: A total of 81 eyes (63 patients) were included of which 39 eyes had undergone prior vitrectomy (PV group) while 42 eyes had not undergone prior vitrectomy (NPV). Baseline characteristics were balanced; however, more patients had proliferative diabetic retinopathy in the PV group vs. the NPV group (21.62% vs 9.38%, respectively). Over 36 months, mean visual acuity (VA) increased in both groups with a tendency for more ETDRS letters being gained in the NPV group (+5.33) vs. the PV group (+2.42). By month 36, central retinal thickness was reduced to ⩽300 µm in two-thirds of the eyes in both groups and the mean change from baseline in intraocular pressure was similar in both groups (+0.50 mmHg −0.75 mmHg; NPV and PV group). Conclusions: These long-term data suggest that the 0.2 μg/day FAc implant is effective in both vitrectomized and non-vitrectomized patients, with a manageable safety profile, and improved VA and reduced supplemental therapies for patients with a suboptimal response to first-line DME therapies. Clinicians may consider utilizing the FAc implant earlier in the DME disease process.

Fortgeschrittenes medulläres Schilddrüsenkarzinom: Vandetanib verbessert das progressionsfreie Überleben

2012 ◽  
Vol 03 (02) ◽  
pp. 93-92
Author(s):  
Alexander Kretzschmar
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Growth Factor Receptor ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Medulläres Schilddrüsenkarzinom ◽  
Epidermal Growth ◽  
Endothelial Growth Factor

Vandetanib ist ein oraler Hemmer des RET-Kinase-, VEGF (Vascular Endothelial Growth Factor Receptor)- und EGFR (Epidermal Growth Factor Receptor)-Signalwegs. In einer zulassungsrelevanten, randomisierten, doppelblinden, placebokontrollierten Phase- III-Studie verlängerte der Tyrosinkinasehemmer das progressionsfreie Überleben (PFS) signifikant länger als Placebo.

scholarly journals Intraokulare Entzündungen bei Brolucizumab-Anwendung

2021 ◽  
Author(s):  
F. G. Holz ◽  
C. Heinz ◽  
A. Wolf ◽  
H. Hoerauf ◽  
U. Pleyer
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Review Committee ◽  
Oder Eine ◽  
Diagnostik Und Therapie ◽  
Factor Inhibitor ◽  
Antientzündliche Therapie ◽  
Endothelial Growth Factor

ZusammenfassungDer VEGF(„vascular endothelial growth factor“)-Inhibitor Brolucizumab ist seit Oktober 2019 in den USA und seit Februar 2020 in Europa zur Behandlung der neovaskulären altersabhängigen Makuladegeneration (nAMD) zugelassen. Grundlage der Zulassung bildeten die randomisierten, doppel-blinden Phase-III-Studien HAWK und HARRIER mit insgesamt 1817 Patienten. Hierbei zeigte Brolucizumab 6 mg (je nach Krankheitsaktivität alle 12 oder alle 8 Wochen verabreicht) eine nichtunterlegene Wirksamkeit in Bezug auf den bestkorrigierten Visus gegenüber Aflibercept 2 mg (alle 8 Wochen verabreicht). Erste Rückmeldungen zum Einsatz von Brolucizumab nach der Marktzulassung in den USA haben einzelne, z. T. schwerwiegende Fälle behandlungsassoziierter intraokularer Entzündungen mit retinaler Vaskulitis und/oder retinaler, vaskulärer Okklusion beschrieben, die teilweise zu einem schweren Visusverlust führten. Die Daten der Zulassungsstudien wurden daraufhin durch ein Safety Review Committee (SRC) unabhängig retrospektiv analysiert. Ziel der vorliegenden Publikation ist es, Anwendern eine Orientierungshilfe aus Autorensicht bei der Therapie einer Brolucizumab-assoziierten intraokularen Entzündung zu bieten. Von zentraler Bedeutung ist hierbei auch eine erweiterte Aufklärung der Patienten über Symptome einer intraokularen Entzündung. Obwohl die Fallserien und die HAWK/HARRIER-Daten es nicht abschließend beantworten, bleiben eine zu späte Detektion, eine unterdosierte antientzündliche Therapie oder eine unbedachte Wiederbehandlung mit Brolucizumab dem Verdacht ausgesetzt, Komplikationen zu verstärken. Ein Stopp der Brolucizumab-Therapie sollte grundsätzlich erfolgen, sobald es nach Gabe des Medikaments zu intraokularen Entzündungen mit oder ohne retinalen Vaskulitiden und oder Gefäßverschluss kam. Abhängig vom Schwerpunkt der Entzündung werden dem Behandler an die Leitlinien und Stellungnahmen angelehnte Empfehlungen für Diagnostik und Therapie dargestellt. Diese Übersichtsarbeit ersetzt nicht die fachgesellschaftlichen Stellungnahmen.

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