Three-Year, Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

Boyer, David S.; Yoon, Young Hee; Belfort, Rubens; Bandello, Francesco; Maturi, Raj K.; Augustin, Albert J.; Li, Xiaoyan; Cui, Huadong; Hashad, Yehia; Whitcup, Scott M.

doi:10.1016/j.ophtha.2014.04.024

Cited by 953 publications

(992 citation statements)

References 29 publications

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“…While there were significant reductions in CMT, the best-corrected visual acuity (BCVA) was unaffected. The Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) study (ClinicalTrials.gov: NCT01492400) subsequently demonstrated anatomical and BCVA improvement with 0.35 mg and 0.7 mg dexamethasone implants compared with a sham procedure in a larger study of 1,048 eyes [58]. The 0.7 mg implant was compared head-to-head with bevacizumab in the prospective randomised controlled BEVORDEX study (ClinicalTrials.gov: NCT01298076), which found similar improvements in visual acuity but superior reduction of CMT in dexamethasone-treated eyes.…”

Section: Anti-inflammatory Therapymentioning

confidence: 99%

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

Bahrami

Zhu

Hong³

et al. 2016

Diabetologia

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Diabetic macular oedema (DMO) is the leading cause of vision loss in patients living with diabetes. DMO results from hyperglycaemia-induced activation of pathways that lead to oxidative stress and release of cytokines, impairing the inner and outer blood-retinal barriers. Improved understanding of the pathophysiological mechanisms leading to DMO have led to the development of effective therapies, including vitreoretinal surgery, laser photocoagulation, intravitreal anti-vascular endothelial growth factor drugs and corticosteroids. Advances in imaging, including fluorescein angiography and optical coherence tomography, have also enhanced diagnosis and management of the condition. Despite these advances, there remain patients who do not respond completely to therapy, reflecting the complex pathophysiology of DMO. These patients may be considered treatment-resistant. In this review, we summarise the pathophysiology of DMO, as well as the available treatments and their mechanism of action. Additionally, we focus on treatment-resistant disease and review the literature on potential options for managing this complication of diabetes.

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Section: Anti-inflammatory Therapymentioning

confidence: 99%

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

Bahrami

Zhu

Hong³

et al. 2016

Diabetologia

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“…36,[42][43][44][45][46][47][48] These treatments are summarised in Table 1. These treatments are particularly useful in eyes with centre-involving DMO.…”

Section: Pharmacologic Treatmentsmentioning

confidence: 99%

A review of therapies for diabetic macular oedema and rationale for combination therapy

Amoaku

Saker

Stewart

2015

Eye

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Diabetic macular oedema (DMO) is responsible for significant visual impairment in diabetic patients. The primary cause of DMO is fluid leakage resulting from increased vascular permeability through contributory anatomical and biochemical changes. These include endothelial cell (EC) death or dysfunction, pericyte loss or dysfunction, thickened basement membrane, loss or dysfunction of glial cells, and loss/change of EC Glycocalyx. The molecular changes include increased reactive oxygen species, pro-inflammatory changes: advanced glycation end products, intracellular adhesion molecule-1, Complement 5-9 deposition and cytokines, which result in increased paracellular permeability, tight junction disruption, and increased transcellular permeability. Laser photocoagulation has been the mainstay of treatment until recently when pharmacological treatments were introduced. The current treatments for DMO target reducing vascular leak in the macula once it has occurred, they do not attempt to treat the underlying pathology. These pharmacological treatments are aimed at antagonising vascular endothelial growth factor (VEGF) or non-VEGF inflammatory pathways, and include intravitreal injections of anti-VEGFs (ranibizumab, aflibercept or bevacizumab) or steroids (fluocinolone, dexamethasone or triamcinolone) as single therapies. The available evidence suggests that each individual treatment modality in DMO does not result in a completely dry macula in most cases. The ideal treatment for DMO should improve vision and improve morphological changes in the macular (eg, reduce macular oedema) for a significant duration, reduced adverse events, reduced treatment burden and costs, and be well tolerated by patients. This review evaluates the individual treatments available as monotherapies, and discusses the rationale and potential for combination therapy in DMO.

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“…Because of its anti-inflammatory properties with a favourable side-effect profile, it became an important treatment option for the macular edema in patients with retinal vein occlusion, non-infectious posterior uveitis and diabetic macular edema [20,21] . To our best knowledge there is a single report by Alten et al [22] , where Ozurdex was used in three acute NAION patients in addition to high-dose systemic steroids.…”

Section: Corticosteroids (Triamcinolone Acetonide Dexamethasone Implmentioning

confidence: 99%

Is There A Role for Intravitreal Pharmacotherapy in the Treatment of Acute Nonarteritic Ischemic Optic Neuropathy?

Parlak¹,

Saatçi²

2016

International Journal of Ophthalmic Research

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Three-Year, Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

Abstract: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

Cited by 953 publications

References 29 publications

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

A review of therapies for diabetic macular oedema and rationale for combination therapy

Is There A Role for Intravitreal Pharmacotherapy in the Treatment of Acute Nonarteritic Ischemic Optic Neuropathy?

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