scholarly journals Repeated Dexamethasone Intravitreal Implant for the Treatment of Diabetic Macular Oedema Unresponsive to Anti-VEGF Therapy: Outcome and Predictive SD-OCT Features

2018 ◽  
Vol 239 (4) ◽  
pp. 205-214 ◽  
Author(s):  
Katja Hatz ◽  
Andreas Ebneter ◽  
Cengiz Tuerksever ◽  
Christian Pruente ◽  
Martin Zinkernagel
Keyword(s):  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Therapy Outcome ◽  
Dexamethasone Intravitreal Implant ◽  
Anti Vegf ◽  
Intravitreal Implant ◽  
Sd Oct

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.

scholarly journals Healthcare resource use and costs of diabetic macular oedema for patients with antivascular endothelial growth factor versus a dexamethasone intravitreal implant in Korea: a population-based study

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030930 ◽  
Author(s):  
HyunJeong Cho ◽  
Kyung Seek Choi ◽  
Joo Yong Lee ◽  
Donghwan Lee ◽  
Nam-Kyong Choi ◽  
...  
Keyword(s):  
Growth Factor ◽  
Healthcare Resource ◽  
Diabetic Macular Oedema ◽  
Eye Care ◽  
Dexamethasone Intravitreal Implant ◽  
Anti Vegf ◽  
Significant Difference ◽  
Intravitreal Implant ◽  
Antivascular Endothelial Growth Factor ◽  
Endothelial Growth Factor

ObjectivesTo estimate the costs and healthcare resources of patients with diabetic macular oedema (DME) who received intravitreal antivascular endothelial growth factor (anti-VEGF) agents or a dexamethasone intravitreal implant (DEX-implant) in Korea.DesignRetrospective cohort study.SettingThe Korean National Health Insurance claim data from 1 January 2015 to 30 June 2017 were retrieved from the Health Insurance Review and Assessment Service.ParticipantsAdult patients with DME who were diagnosed with diabetic retinopathy or DME and received ranibizumab, aflibercept or a DEX-implant in conjunction with intravitreal injection were included. Patients whose primary diagnoses were age-related macular degeneration or retinal vein occlusion were excluded.Main outcome measuresHealthcare resource utilisation and costs related to DME in the 12-month postindex period.ResultsDuring the study period, 182 patients and 414 patients were identified in the anti-VEGF and DEX-implant groups, respectively, and there was no significant difference in the demographic characteristics between the two groups. The outpatient eye care-related medical costs were US$3002.33 for the anti-VEGF group vs US$2250.35 for the DEX-implant group (p<0.0001). After adjusting the relevant covariates based on the generalised linear model, the estimated outpatient eye care-related medical costs were 33% higher in the anti-VEGF group than in the DEX-implant group (p<0.0001, 95% CI 22% to 45%). The utilisation pattern of the two groups showed no significant difference except for the number of intravitreal injections, which was higher in the anti-VEGF group (2.69±2.29) than in the DEX-implant group (2.09±1.37, p<0.001).ConclusionThe average annual eye-related medical cost of the DEX-implant group was significantly lower than that of the anti-VEGF group during the study period, which was mainly due to decreased utilisation of eye care-related injections. Further long-term studies are needed.

Phacoemulsification and dexamethasone intravitreal implant in diabetic patients: A combined approach

2021 ◽  
pp. 112067212110393
Author(s):  
Lucrezia Montrone ◽  
Giancarlo Macinagrossa
Keyword(s):  
Macular Oedema ◽  
Functional Outcomes ◽  
Diabetic Macular Oedema ◽  
Diabetic Patients ◽  
Foveal Thickness ◽  
Systemic Complications ◽  
Dexamethasone Intravitreal Implant ◽  
Intravitreal Implant ◽  
Lens Surgery

Purpose: To analyse the morpho-functional outcomes of dexamethasone intravitreal implant (Ozurdex) injected after lens surgery in diabetic patients with coexisting cataract and macular oedema. Methods: This is a non-randomized, perspective, single-group study on 17 eyes with a diagnosis of cataract and early and advanced diabetic macular oedema. All eyes underwent combined phacoemulsification and Ozurdex injection at the end of surgery and morpho-functional outcomes were analysed in 3 months follow-up. Results: Foveal thickness decreased significantly from 349.6 ± 19.8 (95% CI) at baseline to 310.7 ± 17.5 (95% CI) 90 days after surgery ( p < 0.01). Mean BCVA (LogMAR) improved significantly from 0.38 ± 0.08 (95% CI) at baseline to 0.15 ± 0.06 (95% CI) after 90 days ( p < 0.01). Any ocular or systemic complications were observed during follow-up. Conclusions: Dexamethasone intravitreal implant combined with phacoemulsification may be safe and effective to improve morpho-functional outcomes in diabetic patients with coexisting cataract and macular oedema.

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 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.

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