Statement of the German Society of Ophthalmology, the German Retina Society, and the Professional Association of German
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German Society of Ophthalmology (Deutsche Ophthalmologische Gesellschaft, DOG)2 · German Retina Society e. V. (Retinologische Gesellschaft e. V., RG)3 · Professional Association of German Ophthalmologists (Berufsverband der Augenärzte Deutschlands e. V., BVA)1 1
Professional Association of German Ophthalmologists (Berufsverband der Augenärzte Deutschlands e. V.), Düsseldorf, Germany 2 German Society of Ophthalmology (Deutsche Ophthalmologische Gesellschaft), Munich, Germany 3 German Retina Society (Retinologische Gesellschaft e. V.), Freiburg, Germany
Statement of the German Society of Ophthalmology, the German Retina Society, and the Professional Association of German Ophthalmologists on anti-VEGF therapy of retinopathy of prematurity Released: 18 May 2020 Long text 1. Introduction and definitions The purpose of this statement is to assess the clinical evidence on the use of intravitreal injection of the VEGF inhibitors bevacizumab (Avastin , Roche, Basel, Switzerland), ranibizumab (Lucentis , Novartis, Basel, Switzerland), and aflibercept (Eylea , Bayer, Leverkusen, Germany) for the treatment of ROP. Since there are virtually no clinical data on the use of other VEGFinhibiting drugs than the ones listed
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The German version of this article can be found under https://doi.org/10.1007/s00347020-01170-x. The European Foundation for the Care of Newborn Infants (EFCNI, Munich; Silke Mader, Dr. rer. nat. Johanna Pfeil) was invited to comment as patient representative, and their comments were taken into consideration when writing the guideline.
above, no conclusions can be drawn in the current statement in this regard. Of the three drugs discussed here, only ranibizumab at a dose of 0.2 mg is approved for the treatment of ROP. Bevacizumab and aflibercept represent offlabel use in ROP, with aflibercept being in a phase III trial that could result in a widening of its indication in the future. A considerable amount of clinical data are now available on functional outcome, long-term course, and possible local and systemic adverse effects of bevacizumab and ranibizumab, whereas there are fewer data on aflibercept. A major difference between the three drugs is that bevacizumab and aflibercept have a longer systemic half-life following intravitreal administration compared to ranibizumab. There is evidence that bevacizumab and aflibercept suppress systemic VEGF activity, measured in peripheral blood, over several months after a single intravitreal injection for ROP [9, 11]. This appears not to be the case for ranibizumab due to its signif-
icantly shorter systemic half-life [3, 22, 23]. This is important for the assessment of the treatment’s systemic safety profile since systemic VEGF suppression, theoretically at least, can affect VEGF-dependent processes of tissue and organ maturation, such as neurogenesis and lung maturation (see Sect. 4.3). However, there are no data as yet that unequivocally demonstrate a negative effect of this kind under systemic VEGF suppression. Irrespective of the choice of drug, the general weighing-u
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