One-Year Outcomes of the DA VINCI Study of VEGF Trap-Eye in Eyes with Diabetic Macular Edema

Diana, V.; Nguyen, Quan Dong; Boyer, David S.; Schmidt‐Erfurth, Ursula; Brown, David M.; Vitti, Robert; Berliner, Alyson J.; Gao, Bo; Zeitz, Oliver; Rückert, Ralph I.; Schmelter, Thomas; Sandbrink, Rupert; Heier, Jeff

doi:10.1016/j.ophtha.2012.02.010

Cited by 356 publications

(247 citation statements)

References 31 publications

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“…The target tissues for anti-VEGF therapy are vascular endothelial cells. Examples of existing therapies include monoclonal antibody to VEGF (Krzystolik et al 2002), such as bevacizumab (Avastin) and ranibizumab (Lucentis) (Avery et al 2006;Rosenfeld et al 2005Rosenfeld et al , 2006; aptamers (small oligonucleotides that bind to VEGF), such as pegaptanib (Chakravarthy et al 2006) (Macugen) that binds to and inhibits extracellular VEGF; and VEGF receptor proteins 1 and 2 that are fused to the Fc portion of IgG (Nguyen et al 2006); this acts as a competitive receptor for endogenous VEGF and an example is aflibercept (Heier et al 2012) (Eylea). Binding of these agents to VEGF decreases functional VEGF in the vascular tissues and halts the choroidal neovascularization and leakage from these immature blood vessels that cause damage to the retinal layers.…”

Section: Age-related Macular Degeneration (Amd)mentioning

confidence: 99%

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

Narayanan

Kuppermann

2016

Handbook of Experimental Pharmacology

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Section: Age-related Macular Degeneration (Amd)mentioning

confidence: 99%

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

Narayanan

Kuppermann

2016

Handbook of Experimental Pharmacology

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“…Similar findings were seen in DAVINCI where the PRN group showed no fluctuations on OCT despite this group having received similar number of injections as the bimonthly group during the first year of follow up. 9 Rescue therapy In VIVID and VISTA, the laser group was allowed to receive rescue IAI at 24 weeks. At 52 weeks, the group that received IAI rescue had a gain of 4.2 letters and 3.5 letters compared with 0.2 and 1.2 in the group that received laser alone in VISTA and VIVID respectively.…”

Section: Visual Outcomesmentioning

confidence: 99%

“…1 Drug dosing used in the study The study used the 2 mg dose of aflibercept which was found to be more effective than the 0.5 mg dose in treating DME. 9 It was also used in a PRN protocol which had been previously attempted in the DAVINCI study and was found to be as effective as the 2 mg monthly dosing regimen (2q4 group). 10 The 1.25 mg dose of bevacizumab was the dose previously used in the BOLT study and has proven its efficacy in treating DME.…”

Section: Drcr Protocol T-1 and 2-year Datamentioning

confidence: 99%

Aflibercept in diabetic macular edema: evaluating efficacy as a primary and secondary therapeutic option

Ashraf¹,

Souka²,

Adelman³

et al. 2016

Eye

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The recent results of Protocol T have illustrated the efficacy of aflibercept in the treatment of diabetic macular edema. It also demonstrated that in patients with poor vision (o6/12), aflibercept offers anatomical and visual advantages over ranibizumab and bevacizumab in the first 12 months of treament. At 2 years, the difference between the three drugs decreased with patients with a better baseline VA (69-78) showing a statistically insignificant advantage for ranibizumab compared with aflibercept. These results were achieved using a pro-re nata (PRN) protocol, which was not previously studied in large phase 3 trials, VIVID and VISTA, that chose to compare the 2.0 mg dose in a monthly and bimonthly regimen. In this review article, we analyzed earlier studies such as DAVINCI and VIVID and VISTA to determine which treatment strategy offers the best results; monthly, bimonthly, or PRN. We also studied the different doses for aflibercept used in DAVINCI to determine which is more effective the 0.5 mg dose or the 2.0 mg dose. In addition, we analyzed the recent data from protocol T with regards to visual and anatomic outcomes to try to determine whether these results concur with previous studies. Finally, we discuss the role of aflibercept as a potential alternative to any diabetic macular edema regimen regardless what the primary drug used is.

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“…Diabetic macular edema (DME) is a leading cause of visual loss in developed nations, 1,2 and as the population with diabetes expands, 3 the burden of DME will increase. For many years the standard therapy for DME has been focal macular photocoagulation laser.…”

Section: Introductionmentioning

confidence: 99%

“…[5][6][7][8][9] Vascular endothelial growth factor (VEGF), by increasing vascular permeability, plays an important role in the pathogenesis of DME. 10,11 Studies investigating the intravitreal use of the anti-VEGF agents ranibizumab, [12][13][14][15][16] aflibercept, 2,17 and bevacizumab 18 have also shown favorable results. 19 There are a number of clinical studies suggesting that an attached vitreous may adversely affect the clinical course of DME, or possibly contribute to its pathogenesis.…”

Section: Introductionmentioning

confidence: 99%