Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial

Ahmadieh, Hamid; Ramezani, Alireza; Shoeibi, Nasser; Bijanzadeh, Bijan; Tabatabaei, Azardokht; Azarmina, Mohsen; Soheilian, Masoud; Keshavarzi, Gholamreza; Mohebbi, Mohammadreza

doi:10.1007/s00417-007-0688-0

Cited by 138 publications

(118 citation statements)

References 26 publications

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“…Although some improvements in best-corrected VA (BCVA) has been observed with these agents, robust clinical trial evidence is currently limited. [15][16][17][18][19][20] Ranibizumab (Lucentis Novartis Pharma AG, Basel, Switzerland and Genentech Inc., South San Francisco, CA, USA), a fully humanised monoclonal antibody fragment that binds to multiple variants of VEGF-A, was recently approved by the European Medicines Agency for the treatment of visual impairment due to DME, 21 based on evidence from two pivotal trials, RESOLVE and RESTORE. 4,5 New guidance that considers the availability of this agent and how it fits into the overall treatment algorithm for DME is therefore required.…”

Section: Introductionmentioning

confidence: 99%

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

Bandello¹,

Cunha-Vaz

Chong

et al. 2012

Eye

109

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The current standard therapy for patients with diabetic macular oedema (DME)Ffocal/grid laser photocoagulationFusually does not improve impaired vision, and many patients lose vision despite laser therapy. Recent approval of ranibizumab by the European Medicines Agency to treat visual impairment due to DME fulfils the previously unmet medical need for a treatment that can improve visual acuity (VA) in these patients. We reviewed 1-and 2-year clinical trial findings for ranibizumab used as treatment for DME to formulate evidence-based treatment recommendations in the context of this new therapy. DME with or without visual impairment should be considered for treatment when it fulfils the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant oedema. For DME with centre involvement and associated vision loss due to DME, monthly ranibizumab monotherapy with treatment interruption and re-initiation based on VA stability is recommended. Laser therapy based on ETDRS guidelines is recommended for other forms of clinically significant DME without centre involvement or when no vision loss has occurred, despite centre involvement. Because these recommendations are based on randomised controlled trials of 1-2 years duration, guidance may need updating as long-term ranibizumab data become available and as additional therapeutic agents are assessed in clinical trials.

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Section: Introductionmentioning

confidence: 99%

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

Bandello¹,

Cunha-Vaz

Chong

et al. 2012

Eye

109

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“…At the same time point visual acuity improvements to a statistically significant degree were seen in both the monotherapy and the combined therapy groups compared with sham treatment, and elevation of intraocular pressure in only 8.1% of the combined group. 27 In another study, patients receiving either 1.25 or 2.5 mg bevacizumab showed an OCT-measured reduction in central macular thickness of more than 11% in 43% of treated eyes compared with 28% treated with laser alone at 3 weeks, although by 6 weeks laser treated eyes were more likely to show reduction (50%) than bevacizumab-treated eyes (37%). 25 Although the results for bevacizumab for diabetic macular oedema are modest at best, and the drug is not yet approved for ophthalmologic use, intravitreal injection of bevacizumab has become part of the standard of care in many centres in the United States and the UK in conjunction with photocoagulation and intravitreal steroids.…”

Section: Vegf Inhibitorsmentioning

confidence: 96%

“…[24][25][26][27][28] In one phase 2 randomized double-masked clinical trial, pegaptanib (Macugen) the first aptameric anti-VEGF inhibitor approved for human use, produced improvement in median visual acuity at week 36 with 0.3 mg of drug compared with sham control. In addition, 34% of patients gained two or more lines of vision contrasted with 10% of controls, and mean central thickness decreased in treated patients by 68 compared with 4 mm in sham-treated patients.…”

Section: Vegf Inhibitorsmentioning

confidence: 99%

Optimal current and future treatments for diabetic macular oedema

Blumenkranz

2010

Eye

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“…[134][135][136][137] Ahmadieh et al 134 evaluated bevacizumab alone in comparison to bevacizumab and triamcinolone, and determined that there was no further improvement with the combination compared with bevacizumab alone. Sohelian et al 135,136 compared combination of 1.25 mg bevacizumab and 2 mg triamcinolone with bevacizumab alone and laser photocoagulation alone.…”

Section: Clinical Evidencementioning

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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Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial

Cited by 138 publications

References 26 publications

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

Optimal current and future treatments for diabetic macular oedema

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

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