The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Patients with Diabetic Macular Edema

Diana, V.; Schmidt‐Erfurth, Ursula; González, Víctor H.; Gordon, Carmelina; Tolentino, Michael J.; Berliner, Alyson J.; Vitti, Robert; Rückert, Ralph I.; Sandbrink, Rupert; Stein, David; Yang, Ke; Beckmann, Karola; Heier, Jeff

doi:10.1016/j.ophtha.2011.02.018

Cited by 230 publications

(161 citation statements)

References 22 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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“…In the phase II DAVINCI study compared between 4 different dosing regimens and laser coagulations, the visual gains were lower in the 0.5 mg and 2q8 group and higher in 2q4 and PRN group. 8,9 The low visual gain was consistent for the 2q8 at an earlier stage compared with other groups symbolizing the poor baseline criteria. The baseline characteristics were identical for all groups except 2q8 group with higher percentage of type I DM with proliferative diabetic retinopathy and additionally higher percentage (66%) had received laser grid compared with another group.…”

Section: Efficacymentioning

confidence: 55%

Aflibercept for diabetic macular edema: a concise review

Haridoss

Sundaram

George

et al. 2017

Int J Basic Clin Pharmacol

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Diabetic retinopathy and diabetic macular edema are associated with loss of vision in patients with diabetes worldwide. The treatment requires a multidisciplinary interventional approach. Among the available management options for DME, laser photocoagulation has been the standard of care. Due to its slow progression and inability to reverse the vision loss, an alternative treatment is needed. The role of vascular endothelial growth factors (VEGF) and inflammatory mediators led to the development of anti-VEGF agents, that stimulates retinal vasculogenesis and angiogenesis. Intravitreal aflibercept is an anti-angiogenic soluble decoy receptor with trap technology employed by fusion of multiple endogeneous receptor component, approved for the treatment of DME. Clinical trials of aflibercept comparing it with laser photocoagulation and other anti-VEGF have shown reliable efficacy, providing significantly positive visual and anatomical results. However, treatment regimens with monthly clinical visits and injections, challenge the patients comfort, thereby requiring the need to identify better strategies to lower injection frequencies.

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“…The safety and efficacy of aflibercept in managing DMO has been investigated in the phase II DME And VEGF Trap-Eye INvestigation of Clinical Impact (DAVINCI) trial (ClinicalTrials.gov: NCT00789477), the phase III VISTA/VIVID studies (ClinicalTrials.gov: NCT01363440/NCT01331681) and DRCR.net Protocol T [7,90,91]. DAVINCI and VISTA/VIVID demonstrated superiority of aflibercept in reducing CMT and improving visual acuity compared with ETDRS-guided laser photocoagulation [90,91].…”

Section: Anti-vegf 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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The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Patients with Diabetic Macular Edema

Cited by 230 publications

References 22 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

Aflibercept for diabetic macular edema: a concise review

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

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