Umstellung des Therapieschemas pro re nata (PRN) auf Treat and Extend (T&E) in der intravitrealen Therapie mit Anti-VEGF-Medikamenten in der Praxis oder kleineren Institutionen

Zusammenfassung

Im klinischen Alltag ist das Pro-re-nata-Regime (PRN) weniger gut planbar, bedarf häufigerer Termine und bringt weniger gute klinische Ergebnisse als Treat and Extend (T&E). Aktuelle Literatur spricht für den Nutzen eines Regimewechsels, jedoch fehlt eine praktische Richtlinie. „Best-Practice“-Empfehlungen für die Praxis oder kleinere Institutionen werden hier für alle 3 Phasen angeboten: a) Vorbereitungsphase mit Ändern der Terminorganisation, Schulung von Personal und Patienten, Definieren von Qualitätsparametern, Definieren des Umstellungsschemas (Umstellung für alle zu Termin X oder individuell bei Verschlechterung); b) Umstellungsphase (erhöhter Ressourcenbedarf durch zunächst verkürzte Behandlungsintervalle) und c) Folgephase (Qualitätskontrolle).

Abstract

In everyday practice, intravitreal therapy in an “as needed” regimen (pro re nata, PRN) is less predictable and requires more visits (monitoring and injections taken together) with poorer functional results than with the treat and extend (T&E) regimen. Current literature supports the benefit of a switch. However, practical advice is still missing. This article provides “best practice” recommendations for private practice or smaller institutions for the change from PRN to T&E. The requirements are organisational adjustments, staff training, definition of the scenario triggering the switch (A – functional or anatomical deterioration; B – general switch at a predefined date), counselling of the patients, defining benchmarks for the follow-up of the switch and preparing for higher capacity utilisation during the transition (shorter treatment intervals during the switching phase). Guidance is provided for each phase (a, preparation; b, transition; and c, follow-up).

Schlüsselwörter

anti-VEGF - Behandlungsregime - PRN - Treat and Extend - Umstellung - Algorithmus

Key words

anti-VEGF - treatment regimen - PRN - treat and extend - switch - algorithm

• Literatur

• 1 Brown DM, Kaiser PK, Michels M. et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006; 355: 1432-1444
• 2 Rosenfeld PJ, Heier JS, Hantsbarger G. et al. Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology 2006; 113: 623.e1
• 3 Heier JS, Brown DM, Chong V. et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 2012; 119: 2537-2548
• 4 Mitchell P. A systematic review of the efficacy and safety outcomes of anti-VEGF agents used for treating neovascular age-related macular degeneration: comparison of ranibizumab and bevacizumab. Curr Med Res Opin 2011; 27: 1465-1475
• 5 Regillo CD, Brown DM, Abraham P. et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol 2008; 145: 239-248
• 6 CATT Research Group. Martin DF, Maguire MG. et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011; 364: 1897-1908
• 7 Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Maguire MG, Martin DF. et al. Five-year outcomes with anti-vascular endothelial growth factor treatment of neovascular age-related macular degeneration: the comparison of age-related macular degeneration treatments trials. Ophthalmology 2016; 123: 1751-1761
• 8 Lalwani GA, Rosenfeld PJ, Fung AE. et al. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol 2009; 148: 43-58.e1
• 9 Holz FG, Schmitz-Valckenberg S, Fleckenstein M. Recent developments in the treatment of age-related macular degeneration. J Clin Invest 2014; 124: 1430-1438
• 10 Spaide R. Ranibizumab according to need: a treatment for age-related macular degeneration. Am J Ophthalmol 2007; 143: 679-680
• 11 Berg K, Pedersen TR, Sandvik L. et al. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology 2015; 122: 146-152
• 12 Engelbert M, Zweifel SA, Freund KB. “Treat and extend” dosing of intravitreal antivascular endothelial growth factor therapy for type 3 neovascularization/retinal angiomatous proliferation. Retina 2009; 29: 1424-1431
• 13 Schweizer Fachinformationen Eylea®. Im Internet: http://www.swissmedicinfo.ch Stand: April 2016
• 14 Rote Liste. Im Internet: http://www.rote-liste.de Stand: August 2016
• 15 Deutsche Ophthalmologische Gesellschaft. Die Anti-VEGF-Therapie bei der neovaskulären altersabhängigen Makuladegeneration: Therapeutische Strategien. Stellungnahme der Deutschen Ophthalmologischen Gesellschaft, der Retinologischen Gesellschaft und des Berufsverbandes der Augenärzte Deutschlands – November 2014. Im Internet: http://cms.augeninfo.de/fileadmin/stellungnahmen/Anti-VEGF-Therapie_bei_der_neovask_Therapeut_Strategie.pdf Stand: Oktober 2016
• 16 Wykoff C, Croft DE, Brown DM. et al. Prospective trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration. TREX-AMD 1-year results. Ophthalmology 2015; 122: 2514-2522
• 17 Hatz K, Prünte C. Treat and extend versus pro re nata regimens of ranibizumab in neovascular age-related macular degeneration: a comparative 12 month study. Acta Ophthalmol 2016;
• 18 Chin-Yee D, Eckt T, Folwer S. et al. A systematic review of as needed versus treat and extend ranibizumab or bevacizumab treatment regimens for neovascular age-related macular degeneration. Br J Ophthalmol 2015;
• 19 Arnold JJ, Campain A, Barthelmes D. et al. Two-year outcomes of “treat and extend” intravitreal therapy for neovascular age-related macular degeneration. Ophthalmology 2015; 122: 1212-1219
• 20 Thorell MR, Nunes RP, Chen GW. et al. Response to aflibercept after frequent re-treatment with bevacizumab or ranibizumab in eyes with neovascular AMD. Ophthalmic Surg Lasers Imaging Retina 2014; 45: 526-533
• 21 Rayess N, Houston 3rd SK, Gupta OP. et al. Treatment outcomes after 3 years in neovascular age-related macular degeneration using a treat-and-extend regimen. Am J Ophthalmol 2015; 159: 3-8.e1
• 22 Abedi F, Wickremasinghe S, Islam AF. et al. Anti-VEGF treatment in neovascular age-related macular degeneration. A treat-and-extend protocol over 2 years. Retina 2014; 34: 1531-1538
• 23 Toalster N, Russell M, Ng P. A 12-month prospective trial of inject and extend regimen for ranibizumab treatment of age-related macular degeneration. Retina 2013; 33: 1351-1358
• 24 Shienbaum G, Gupta OP, Fecarotta C. et al. Bevacizumab for neovascular age-related macular degeneration using a treat-and-extend regimen: clinical and economic impact. Am J Ophthalmol 2012; 153: 468-473.e1
• 25 Oubraham H, Cohen SY, Samimi S. et al. Inject and extend dosing versus dosing as needed: a comparative retrospective study of ranibizumab in exudative age-related macular degeneration. Retina 2011; 31: 26-30
• 26 Gupta OP, Shienbaum G, Patel AH. et al. A treat and extend regimen using ranibizumab for neovascular age-related macular degeneration clinical and economic impact. Ophthalmology 2010; 117: 2134-2140
• 27 Engelbert M, Zweifel SA, Freund KB. Long-term follow-up for type 1 (subretinal pigment epithelium) neovascularization using a modified “treat and extend” dosing regimen of intravitreal antivascular endothelial growth factor therapy. Retina 2010; 30: 1368-1375
• 28 Rush RB, Rush SW, Aragon AV. et al. Evaluation of choroidal neovascularization with indocyanine green angiography in neovascular age-related macular degeneration subjects undergoing intravitreal bevacizumab therapy. Am J Ophthalmol 2014; 158: 337-344
• 29 Regillo CD. Prospective, multicenter investigation of aflibercept treat and extend therapy for neovascular age-related macular degeneration (ATLAS study) 2 year results. Presented at: American Academy of Ophthalmology. Nov. 14, 2015; Las Vegas.
• 30 Hatz K, Prünte C. Changing from a pro re nata treatment regimen to a treat and extend regimen with ranibizumab in neovascular age-related macular degeneration. Br J Ophthalmol 2016; 100: 1341-1345
• 31 Freund KB, Korobelnik JF, Devenyi R. et al. Treat-and-extend regimens with anti-VEGF Agents in retinal diseases. A literature review and consensus recommendations. Retina 2015; 35: 1489-1506