2 mg EYLEA
0.3 mg ranibizumab
125 mg bevacizumab
2 mg EYLEA
0.3 mg ranibizumab
125 mg bevacizumab
VIVID: Mean change in BCVA through Week 52
EYLEA ®2 mg administered every month (4 weeks) for the first 5 months, followed by once every 2 months (n=135)
Laser photocoagulation administered as needed, no more often than every 12 weeks (n=132)
- In Protocol T, the dose of ranibizumab tested was 0.3 mg (US-approved dosage), while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA or ranibizumab.
- The EURETINA Guidelines included data from Protocol T where the dose of ranibizumab tested was 0.3 mg (US-approved dosage), while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA or ranibizumab.
- Bevacizumab has no marketing authorization for use in ophthalmic indications.
- Meta-analysis using Cochrane methods (based on a search of databases conducted in April 2017) of RCTs with anti-VEGF agents in DME patients, focused on the three most commonly used drugs: EYLEA, ranibizumab, and unlicensed bevacizumab. The analysis included 24 studies and 6007 participants in total. A total of 17 studies (4031 eyes) were assessed for gains of 3 or more VA lines at one year. This Cochrane meta-analysis included data from Protocol T where the dose of ranibizumab tested was 0.3 mg (US-approved dosage) while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA or ranibizumab.
- Pairwise comparisons (adjusted for multiple comparisons) over 2 years: ranibizumab (52%) vs EYLEA (41%; P=0.04)
- In the VIVID and VISTA RCTs patients were randomized to receive EYLEA 2 mg either every 4 or 8 weeks after 5 monthly doses, or laser control. From Week 24, if rescue treatment criteria were met, EYLEA patients received active laser, and laser control patients received 5 monthly doses of EYLEA, followed by dosing every 8 weeks. From Week 100, laser control patients who had not received EYLEA rescue treatment received EYLEA as needed per retreatment criteria.
- EYLEA ® (aflibercept solution for injection) Summary of Product Characteristics. Berlin, Germany: Bayer Pharma AG.
- A Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121:2247-2254.
- Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016;123:1351-1359.
- Jampol LM, Glassman AR, Bressler NM, Wells JA, Ayala AR; for the Diabetic Retinopathy Clinical Research Network. Anti-vascular endothelial growth factor comparative effectiveness trial for diabetic macular edema: additional efficacy post hoc analyses of a randomized clinical trial. JAMA Ophthalmol. 2016;134:1429-1434.
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- Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237:185-22.pub5.
- Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372:1193-1203.
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- Papadopoulos N, Martin J, Ruan Q, et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap,ranibizumab and bevacizumab. Angiogenesis. 2012;15;171-185.
- Krizova L, Kalousova M, Kubena AA, et al. Correlation of vitreous vascular endothelial growth factor and uric acid concentration using optical coherence tomography in diabetic macular edema. J Ophthalmol. 2015;478509.
- Al Kahtani E, Xu Z, Al Rashead S, et al. Vitreous levels of placental growth factor correlate with activity of proliferative diabetic retinopathy and are not influenced by bevacizumab treatment. Eye (Lond). 2017;31:529-536.
- Nguyen QD, De Falco S, Behar-Cohen F, et al. Placental growth factor and its potential role in diabetic retinopathy and other ocular neovascular diseases. Acta Ophthalmol. 2018;96:e1-e9.
- Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies.Ophthalmology. 2016;123:2376-2385.
- Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122:2044-2052.