A Prospective Randomized Trial of Intravitreal Bevacizumab or Laser Therapy in the Management of Diabetic Macular Edema (BOLT Study)

Michaelides, Michel; Kaines, Andrew; Hamilton, Robin; Fraser‐Bell, Samantha; Rajendram, Ranjan; Quhill, Fahd; Boos, Christopher J.; Xing, Wen; Egan, Catherine; Pető, Tünde; Bunce, Catey; Leslie, Richard; Hykin, Philip

doi:10.1016/j.ophtha.2010.03.045

Cited by 483 publications

(390 citation statements)

References 28 publications

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“…57,58 A large prospective trial comparing bevacizumab injections with laser produced similar results (8.0 letters vs loss of 0.5 letter). 59 In a phase 3 trial, oral ruboxistaurin, a protein kinase C inhibitor, decreased the probability of diabetic macular edema progression. 60 Retinal Vein Occlusions Branch retinal vein occlusions (BRVOs) and central retinal vein occlusions (CRVOs) afflict 1.8% and 0.5%, respectively, of the population aged 50 years or older.…”

Section: Diabetic Retinopathymentioning

confidence: 99%

The Expanding Role of Vascular Endothelial Growth Factor Inhibitors in Ophthalmology

Stewart

2012

Mayo Clinic Proceedings

166

105

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Vascular endothelial growth factor (VEGF) plays an important role in both physiologic and pathologic angiogenesis and contributes to increased permeability across both the blood-retinal and blood-brain barriers. After 2 decades of extensive research into the VEGF families and receptors, specific molecules have been targeted for drug development, and several medications have received US Food and Drug Administration approval. Bevacizumab, a full-length antibody against VEGF approved for the intravenous treatment of advanced carcinomas, has been used extensively in ophthalmology for exudative age-related macular degeneration, diabetic retinopathy, retinal vein occlusions, retinopathy of prematurity, and other chorioretinal vascular disorders. Pegaptanib and ranibizumab have been developed specifically for intraocular use, whereas the soon-to-be-introduced aflibercept (VEGF Trap-Eye) is moving through clinical trials for both intraocular and systemic use. Although these drugs exhibit excellent safety profiles, ocular and systemic complications, particularly thromboembolic events, remain a concern in patients receiving therapy. Patients experiencing adverse events that may be related to VEGF suppression should be carefully evaluated by both the ophthalmologist and the medical physician to reassess the need for intraocular therapy and explore the feasibility of changing medications. For this review a search of PubMed from January 1, 1985 through April 15, 2011, was performed using the following terms (or combination of terms): vascular endothelial growth factors, VEGF, age-related macular degeneration, diabetic retinopathy, retina vein occlusions, retinopathy of prematurity, intravitreal injections, bevacizumab, ranibizumab, and VEGF Trap. Studies were limited to those published in English. Other articles were identified from bibliographies of retrieved articles and archives of the author.

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Section: Diabetic Retinopathymentioning

confidence: 99%

The Expanding Role of Vascular Endothelial Growth Factor Inhibitors in Ophthalmology

Stewart

2012

Mayo Clinic Proceedings

166

105

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“…Ranibizumab has shown extensive trial data of benefit in diabetic macular oedema for example in the large DRCR.net 14 and bevacizumab, unlicensed for ocular use, showed improved outcomes in patients with macular oedema compared with laser therapy in the smaller BOLT study. 15 Other trials of new medical therapies have focused on blockade of the protein kinase C pathway (ruboxistaurin) showing an effect with reduction of laser treatment and visual loss in patients with diabetes with maculopathy, 16 such that this agent has an approvable letter from the US FDA while further trial data are completed.…”

Section: Management Prioritiesmentioning

confidence: 99%

Medical management of diabetic retinopathy: fenofibrate and ACCORD Eye studies

Wright

Dodson

2011

Eye

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The approach of all ophthalmologists, diabetologists and general practitioners seeing patients with diabetic retinopathy should be that good control of blood glucose, blood pressure and plasma lipids are all essential components of modern medical management. The more recent data on the use of fenofibrate in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye studies is reviewed. In FIELD, fenofibrate (200 mg/day) reduced the requirements for laser therapy and prevented disease progression in patients with preexisting diabetic retinopathy. In ACCORD Eye, fenofibrate (160 mg daily) with simvastatin resulted in a 40% reduction in the odds of retinopathy progressing over 4 years, compared with simvastatin alone. This occurred with an increase in HDL-cholesterol and a decrease in the serum triglyceride level in the fenofibrate group, as compared with the placebo group, and was independent of glycaemic control. We believe fenofibrate is effective in preventing progression of established diabetic retinopathy in type 2 diabetes and should be considered for patients with pre-proliferative diabetic retinopathy and/or diabetic maculopathy, particularly in those with macular oedema requiring laser.

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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

110

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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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A Prospective Randomized Trial of Intravitreal Bevacizumab or Laser Therapy in the Management of Diabetic Macular Edema (BOLT Study)

Cited by 483 publications

References 28 publications

The Expanding Role of Vascular Endothelial Growth Factor Inhibitors in Ophthalmology

The Expanding Role of Vascular Endothelial Growth Factor Inhibitors in Ophthalmology

Medical management of diabetic retinopathy: fenofibrate and ACCORD Eye studies

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

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