Comparative effectiveness of aflibercept for the treatment of patients with neovascular age-related macular degeneration

Thomas, Michael B.; Mousa, Shaymaa S; Mousa, Shaker A.

doi:10.2147/opth.s29974

Cited by 32 publications

(19 citation statements)

References 38 publications

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“…Either sharing multiple doses of ziv-aflibercept from a single vial 7–9 or using compounded ziv-aflibercept can substantially reduce the cost of treatment and with a softer regimen of 8 injections instead of 12 injections in the first year, ziv-aflibercept would appear theoretically to be more cost effective than bevacizumab ( table 3 ), 23–25 with unique features of high binding affinity, long half-life, and binding tightly to three isoforms of growth factors VEGF-A, VEGF-B and placental growth factor. 23 Unlike aflibercept, ziv-aflibercept is formulated in hypertonic sucrose, a condition that theoretically prevents its intraocular use because hypertonic preparations could damage the retina. According to Silver, 5 the manufacturing differences between intraocular aflibercept and intravenous ziv-aflibercept are proprietary but unlikely to account for the 100-fold price differential.…”

Section: Discussionmentioning

confidence: 99%

Ziv-aflibercept in macular disease

et al. 2015

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Background/aimsAflibercept is an approved therapy for neovascular age-related macular degeneration (AMD) and diabetic macular oedema (DME). In vitro and in vivo studies did not detect toxicity to the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept. Our purpose is to determine if ziv-aflibercept can be used in AMD and DME without ocular toxicity, to test the stability of ziv-aflibercept, and to do a cost analysis.MethodsProspectively, consecutive patients with AMD or DME and poor vision underwent one intravitreal injection of 0.05 mL of fresh filtered ziv-aflibercept (1.25 mg). Monitoring of best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal structure by spectral domain optical coherence tomography was done at 1 day and 1 week after injection. Ziv-aflibercept activity over 4 weeks was measured by capturing vascular endothelial growth factor by ELISA.ResultsThere were no signs of retinal toxicity, intraocular inflammation or change in lens status in four eyes with AMD and two eyes with DME. Visual acuity improved (p=0.05) and central foveal thickness decreased in all patients (p=0.05). Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous saving compared with aflibercept or ranibizumab.ConclusionsOff-label use of ziv-aflibercept improves visual acuity without ocular toxicity and may offer a cheaper alternative to the same molecule aflibercept.Trial registration numberNCT02173873.

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Section: Discussionmentioning

confidence: 99%

Ziv-aflibercept in macular disease

et al. 2015

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“…For this, we compared the mean number of units of each agent dispensed (i.e., the primary study outcome) for the final study cohorts at 6 and 12 months after the index date (herein referred to as month 6 and month 12). We concluded that there was no difference in the number of dispensed units of ranibizumab versus aflibercept if the 95% CI limits of the adjusted mean difference (ranibizumab−aflibercept) did not exceed 1.00 unit, which was deemed to be meaningful from a pharmacy administration and health authority reimbursement scheme perspective [ 29 ].…”

Section: Methodsmentioning

confidence: 99%

Dispensing Patterns of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration: A Retrospective Cohort Study in Australia

Skelly

Carius²,

Bezlyak

et al. 2017

Adv Ther

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IntroductionAnti-vascular endothelial growth factor therapy is the standard of care for neovascular age-related macular degeneration (nAMD). The dosage of two licensed agents, ranibizumab and aflibercept, was established through clinical trials; however, it is unclear if either agent is administered as recommended in routine clinical practice. Using pharmacy claims data, we investigated if the dispensing patterns of ranibizumab differ from those of aflibercept 6 and 12 months after treatment initiation.MethodsPrescription data retrieved from the Australian IMS® AUS LRx database were used to identify nAMD patients with one or more claims for ranibizumab or aflibercept between December 1, 2012, and March 31, 2015, with follow-up of at least 6 months. The number of ranibizumab and aflibercept units dispensed was adjusted for baseline patient Medication-Based Disease Burden Index (MBDBI) scores. No difference in the number of ranibizumab versus aflibercept units dispensed was concluded if the 95% confidence interval (CI) limits of the adjusted mean difference between the study cohorts were 1.00 unit or less.ResultsBaseline patient MBDBI scores were similar for the ranibizumab (N = 1235) and aflibercept (N = 959) cohorts. The adjusted mean (standard deviation) number of units dispensed was 5.3 (1.3) versus 5.1 (1.4) at month 6 and 8.9 (2.2) versus 8.9 (2.3) at month 12. The 95% CI limits of the adjusted mean difference did not exceed 1.00 unit dispensed at either time point: 95% CI of 0.09 to 0.32 for an adjusted mean difference of 0.20 at month 6 and −0.23 to 0.30 for an adjusted mean difference of 0.04 at month 12. Mean (standard deviation) dispensing intervals were comparable for both cohorts: 35.3 (19.2) days versus 36.8 (20.0) days at month 6 (adjusted mean difference −1.59 days; 95% CI –2.51 to −0.67 days) and 41.2 (20.9) days versus 41.6 (20.4) days at month 12 (adjusted mean difference −0.40 days; 95% CI −1.70 to 0.91 days).ConclusionsRanibizumab and aflibercept are dispensed in a similar manner by Australian pharmacies during the first year of treatment.FundingNovartis Pharma AG.

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“… 4 Vascular endothelial growth factor (VEGF) is widely considered the main growth factor leading to the increased angiogenesis within the eyeballs. 5 Anti-VEGF treatment can prevent further neovascularization from wet AMD. The first breakthrough in anti-VEGF therapy for the treatment of wet AMD treatment was pegaptanib (Macugen; Eyetech Inc, Palm Beach Gardens, FL, USA) in 2004.…”

Section: Introductionmentioning

confidence: 99%

Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis

Ba¹,

Peng²,

Xu³

et al. 2015

DDDT

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AimsAge-related macular degeneration (AMD) is the main cause of blindness. Anti-vascular endothelial growth factor is used to prevent further neovascularization due to wet AMD. The purpose of this systematic review was to investigate the effect and protocol of anti-vascular endothelial growth factor treatment on wet AMD.MethodsA comprehensive literature search was performed in PubMed, Embase, the Cochrane Library, CNKI, and reference lists. Meta-analysis was performed using Stata12.0 software, best corrected visual acuity (BCVA), retinal thickness, and lesion size were evaluated.ResultsTwelve randomized controlled trials spanning from 2010 to 2014 and involving 5,225 patients were included. A significant difference was observed between the intravitreal ranibizumab (IVR) group and the intravitreal bevacizumab group (standard mean difference =−0.14, 95% confidence interval [CI] =−0.23 to −0.05). No significant differences were observed in best corrected VA, retinal thickness, or lesion size between IVR and the intravitreal aflibercept group. Compared to monthly injection, IVR as-needed injections (PRN) can raise VA by 1.97 letters (weighted mean difference =1.97, 95% CI =0.14–3.794). Combination therapy of IVR and photodynamic therapy can significantly raise VA by 2.74 letters when combined with IVR monotherapy (weighted mean difference =2.74, 95% CI =0.26–5.21).ConclusionThe superiority remains unclear between IVR and intravitreal bevacizumab in the treatment of neovascular AMD. Intravitreal aflibercept dosed every 2 months required fewer injection times, but produced similar efficacy as monthly IVR. IVR PRN could significantly increase VA. Combined with photodynamic therapy, IVR therapy could also increase VA effectively.

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Comparative effectiveness of aflibercept for the treatment of patients with neovascular age-related macular degeneration

Cited by 32 publications

References 38 publications

Ziv-aflibercept in macular disease

Ziv-aflibercept in macular disease

Dispensing Patterns of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration: A Retrospective Cohort Study in Australia

Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis

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