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DOI: 10.1055/s-2007-963356
© Georg Thieme Verlag KG Stuttgart · New York
Stellungnahme der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands zu aktuellen therapeutischen Möglichkeiten bei der neovaskulären altersabhängigen Makuladegeneration
Stand Juni 2007Position of the Retinological Society, the German Ophthalmological Society and the Professional Association of Ophthalmologists in Germany on the Current Therapeutic Possibilities for Neovascular Age-related Macular DegenerationStatus as of June 2007Publication History
Eingegangen: 21.6.2007
Angenommen: 25.6.2007
Publication Date:
26 July 2007 (online)
![](https://www.thieme-connect.de/media/klimo/200707/lookinside/thumbnails/10.1055-s-2007-963356-1.jpg)
Zusammenfassung
Die Rahmenbedingungen in der Behandlung der exsudativen AMD[1] haben sich seit der letzten Stellungnahme der Fachgesellschaften erheblich verändert. Nach der Zulassung von Pegaptanib zur intraokularen Therapie der AMD ist seit Februar 2007 auch Ranibizumab in Deutschland zugelassen. Zusätzlich ist die Qualitätssicherungsvereinbarung zur photodynamischen Therapie am Augenhintergrund novelliert worden, wobei neue Bestimmungen zur Behandlung der okkulten CNV aufgenommen wurden und dem Vorschlag der Fachgesellschaften zur Präzisierung der Nomenklatur sub- bzw. extrafovealer CNVs gefolgt wurde. Es war deshalb notwendig, die Empfehlungen der Fachgesellschaften zur Therapie der AMD den geänderten Rahmenbedingungen anzupassen.
Abstract
The basic conditions in the management of exudative age-related macular degeneration have changed considerably since the last statement of the German professional associations in 2006. While Pegaptanib was approved in Germany already in 2006 Ranibizumab was approved for the treatment of exudative macular degeneration in Germany in February 2007. More over the quality assurance regulations for the photodynamic treatment of choroidal neovascularizations with Verteporfin were modified including the treatment of occult lesions and implementing a simplified classification of extra- and subfoveal lesions. Consequently modification of the recommendations for the non-surgical treatment of exudative age-related macular degeneration appeared inevitable.
Schlüsselwörter
altersabhängige Makuladegeneration - Behandlungsrichtlinien
Key words
age related macular degeneration - preferred practice pattern
1 Ein Glossar mit den verwendeten Abkürzungen findet sich am Ende des Textes.
Literatur
- 1 Stellungnahme zu aktuellen therapeutischen Möglichkeiten bei der neovaskularen altersabhängigen Makuladegeneration. Klin Monatsbl Augenheilkd. 2006; 223 271-278
- 2 Bekanntmachungen: Vereinbarung von Qualitätssicherungsmaßnahmen nach § 135 Abs. 2 SGB V zur photodynamischen Therapie am Augenhintergrund (Qualitätssicherungsvereinbarung PDT). Dtsch Ärztebl. 2006; 103 A 2575-2577
- 3 Bekanntmachungen: Beschluss des Gemeinsamen Bundesausschusses über eine Änderung der Richtlinie Methoden vertragsärztliche Versorgung in Anlage I „Anerkannte Untersuchungs- oder Behandlungsmethoden” vom 19. September 2006. Dtsch Ärztebl. 2006; 104 A-74
- 4 Pauleikhoff D, Bornfeld N, Gabel V P. et al . Konsenspapier der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbandes der Augenärzte - Stellungnahme zur aktuellen Therapie der neovaskulären AMD. Klin Monatsbl Augenheilkd. 2005; 222 381-388
-
5 http://www.novartisophthalmics.visudyne.de/Visudyne/index_pro.xml?view = db&menuid = 1663&linkid = 3859
- 6 Gillies M C, Simpson J M, Luo W. et al . A randomized clinical trial of a single dose of intravitreal triamcinolone acetonide for neovascular age-related macular degeneration: one-year results. Arch Ophthalmol. 2003; 121 667-673
- 7 Jonas J B, Spandau U H, Kamppeter B A. et al . Duration of the effect of intravitreal triamcinolone acetonide in eyes with exudative age-related macular degeneration. J Ocul Pharmacol Ther. 2006; 22 194-199
- 8 Jonas J B, Spandau U H, Kamppeter B A. et al . Repeated intravitreal injection of triamcinolone for exudative age-related macular degeneration. Ophthalmic Res. 2006; 38 324-328
- 9 Jonas J B, Spandau U H, Kamppeter B A. et al . Follow-up after intravitreal triamcinolone acetonide for exudative age-related macular degeneration. Eye. 2007; 21 387-394
- 10 Russell S R, Hudson H L, Jerdan J A. Anecortave acetate for the treatment of exudative age-related macular degeneration - a review of clinical outcomes. Surv Ophthalmol. 2007; 52 (Suppl 1) S79-90
- 11 Slakter J S, Bochow T W, D’Amico D J. et al . Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration. Ophthalmology. 2006; 113 3-13
- 12 Gonzales C R. Enhanced efficacy associated with early treatment of neovascular age-related macular degeneration with pegaptanib sodium: an exploratory analysis. Retina. 2005; 25 815-827
- 13 Gragoudas E S, Adamis A P, Cunningham E T Jr. et al . Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004; 351 2805-2816
- 14 Chakravarthy U, Adamis A P, Cunningham E T Jr. et al . Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration. Ophthalmology. 2006; 113 1508-1521
- 15 Hughes M S, Sang D N. Safety and efficacy of intravitreal bevacizumab followed by pegaptanib maintenance as a treatment regimen for age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2006; 37 446-454
- 16 Brown D M, Kaiser P K, Michels M. et al . Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006; 355 1432-1444
- 17 Rosenfeld P J, Brown D M, Heier J S. et al . Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006; 355 1419-1431
- 18 Novartis Pharma GmbH .Fachinformation Lucentis®. Rote Liste GmbH 2007
-
19 http://www.novartis.de/Lucentis
- 20 Liew G, Mitchell P. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2007; 356 747-748
- 21 Heiduschka P, Fietz H, Hofmeister S. et al . Penetration of bevacizumab through the retina after intravitreal injection in the monkey. Invest Ophthalmol Vis Sci. 2007; 48 2814-2823
- 22 Spitzer M S, Yoeruek E, Sierra A. et al . Comparative antiproliferative and cytotoxic profile of bevacizumab (Avastin), pegaptanib (Macugen) and ranibizumab (Lucentis) on different ocular cells. Graefes Arch Clin Exp Ophthalmol. 2007; im Druck
- 23 Moschos M M, Brouzas D, Apostolopoulos M. et al . Intravitreal use of bevacizumab (Avastin) for choroidal neovascularization due to ARMD: a preliminary multifocal-ERG and OCT study: Multifocal-ERG after use of bevacizumab in ARMD. Doc Ophthalmol. 2007; 114 37-44
- 24 Bakri S J, Snyder M R, Pulido J S. et al . Six-month stability of bevacizumab (Avastin) binding to vascular endothelial growth factor after withdrawal into a syringe and refrigeration or freezing. Retina. 2006; 26 519-522
- 25 Peters S, Julien S, Heiduschka P. et al . Anti-permeability and anti-proliferative effects of standard and frozen bevacizumab on choroidal endothelial cells. Br J Ophthalmol. 2007; 91 827-831
- 26 Chen C Y, Wong T Y, Heriot W J. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration: a short-term study. Am J Ophthalmol. 2007; 143 510-512
- 27 Aisenbrey S, Ziemssen F, Volker M. et al . Intravitreal bevacizumab (Avastin) for occult choroidal neovascularization in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2007; 245 941-948
- 28 Yoganathan P, Deramo V A, Lai J C. et al . Visual improvement following intravitreal bevacizumab (Avastin) in exudative age-related macular degeneration. Retina. 2006; 26 994-998
- 29 Jonas J B, Libondi T, Ihloff A K. et al . Visual acuity change after intravitreal bevacizumab for exudative age-related macular degeneration in relation to subfoveal membrane type. Acta Ophthalmol Scand. 2007; im Druck;
- 30 Mennel S, Callizo J, Schmidt J C. et al . Acute retinal pigment epithelial tear in the untreated fellow eye following repeated bevacizumab (Avastin®) injections. Acta Ophthalmol Scand. 2007; im Druck;
- 31 Avery R L, Pearlman J, Pieramici D J. et al . Intravitreal bevacizumab (Avastin) in the treatment of proliferative diabetic retinopathy. Ophthalmology. 2006; 113 1695-1705
- 32 Fung A E, Rosenfeld P J, Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol. 2006; 90 1344-1349
- 33 Kernt M, Neubauer A S, Kampik A. Intravitreal bevacizumab (Avastin) treatment is safe in terms of intraocular and blood pressure. Acta Ophthalmol Scand. 2007; 85 119-120
- 34 Aggio F B, Farah M E, Melo G B. et al . Acute endophthalmitis following intravitreal bevacizumab (Avastin) injection. Eye. 2007; 21 408-409
- 35 Gelisken de F, Ziemssen F, Voelker M. et al . Retinal pigment epithelial tear following intravitreal bevacizumab injection for neovascular age-related macular degeneration. Acta Ophthalmol Scand. 2006; 84 833-834
- 36 Meyer C H, Mennel S, Schmidt J C. et al . Acute retinal pigment epithelial tear following intravitreal bevacizumab (Avastin) injection for occult choroidal neovascularisation secondary to age related macular degeneration. Br J Ophthalmol. 2006; 90 1207-1208
- 37 Spaide R F, Sorenson J, Maranan L. Combined photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide for choroidal neovascularization. Ophthalmology. 2003; 110 1517-1525
- 38 Spaide R F, Sorenson J, Maranan L. Combined photodynamic therapy and intravitreal triamcinolone for nonsubfoveal choroidal neovascularization. Retina. 2005; 25 685-690
- 39 Augustin A J, Schmidt-Erfurth U. Verteporfin therapy combined with intravitreal triamcinolone in all types of choroidal neovascularization due to age-related macular degeneration. Ophthalmology. 2006; 113 14-22
- 40 Spaide R F. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006; 141 149-156
- 41 Jonas J B, Kreissig I, Spandau U H. et al . Infectious and noninfectious endophthalmitis after intravitreal high-dosage triamcinolone acetonide. Am J Ophthalmol. 2006; 141 579-580
- 42 Augustin A J, Schmidt-Erfurth U. Verteporfin and intravitreal triamcinolone acetonide combination therapy for occult choroidal neovascularization in age-related macular degeneration. Am J Ophthalmol. 2006; 141 638-645
- 43 Chan W M, Lai T Y, Wong A L. et al . Combined photodynamic therapy and intravitreal triamcinolone injection for the treatment of subfoveal choroidal neovascularisation in age related macular degeneration: a comparative study. Br J Ophthalmol. 2006; 90 337-341
- 44 Liggett P E, Colina J, Chaudhry N A. et al . Triple therapy of intravitreal triamcinolone, photodynamic therapy, and pegaptanib sodium for choroidal neovascularization. Am J Ophthalmol. 2006; 142 1072-1074
- 45 Augustin A J, Puls S, Offermann I. Triple therapy for choroidal neovascularization due to age-related macular degeneration: verteporfin PDT, bevacizumab, and dexamethasone. Retina. 2007; 27 133-140
- 46 Shen J, Samul R, Silva R L. et al . Suppression of ocular neovascularization with siRNA targeting VEGF receptor 1. Gene Ther. 2006; 13 225-234
- 47 Wijngaarden van P, Coster D J, Williams K A. Inhibitors of ocular neovascularization: promises and potential problems. JAMA. 2005; 293 1509-1513
-
48 http://www.cebm.net/downloads/Oxford_CEBM_Levels_5.rtf
- 49 Francke R, Hart D. Off label use - Arzneimittelrechtliche, haftungsrechtliche, berufsrechtliche und sozialrechtliche Fragen. Die Sozialgerichtsbarkeit. 2003; 50 653-664
- 50 Parrish R 2nd , Sternberg P Jr. Does „off-label” mean off limits for patient care?. Am J Ophthalmol. 2007; 143 853-855
- 51 Macular Photocoagulation Study Group . Argon laser photocoagulation for neovascular maculopathy. Five-year results from randomized clinical trials. Arch Ophthalmol. 1991; 109 1109-1114
- 52 Voelker M, Gelisken F, Ziemssen F. et al . Verteporfin photodynamic therapy for extrafoveal choroidal neovascularisation secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2005; 243 1241-1246
- 53 Dhalla M S, Shah G K, Blinder K J. et al . Combined photodynamic therapy with verteporfin and intravitreal bevacizumab for choroidal neovascularization in age-related macular degeneration. Retina. 2006; 26 988-993
- 54 Axer-Siegel R, Ehrlich R, Rosenblatt I. et al . Photodynamic therapy for occult choroidal neovascularization with pigment epithelium detachment in age-related macular degeneration. Arch Ophthalmol. 2004; 122 453-459
- 55 Axer-Siegel R, Ehrlich R, Avisar I. et al . Combined photodynamic therapy and intravitreal triamcinolone acetonide injection for neovascular age-related macular degeneration with pigment epithelium detachment. Ophthalmic Surg Lasers Imaging. 2006; 37 455-461
- 56 Sutter F K, Kurz-Levin M M, Fleischhauer J. et al . Macular atrophy after combined intravitreal triamcinolone acetonide (IVTA) and photodynamic therapy (PDT) for retinal angiomatous proliferation (RAP). Klin Monatsbl Augenheilkd. 2006; 223 376-378
- 57 Nicolo M, Ghiglione D, Lai S. et al . Retinal angiomatous proliferation treated by intravitreal triamcinolone and photodynamic therapy with verteporfin. Graefes Arch Clin Exp Ophthalmol. 2006; 244 1336-1338
- 58 Bolz M, Michels S, Geitzenauer W. et al . Effect of systemic bevacizumab therapy on retinal pigment epithelial detachment. Br J Ophthalmol. 2006; 91 785-789
- 59 Gamulescu M A, Framme C, Sachs H. RPE-rip after intravitreal bevacizumab (Avastin) treatment for vascularised PED secondary to AMD. Graefes Arch Clin Exp Ophthalmol. 2007; 245 1037-1040
- 60 Aiello L P, Brucker A J, Chang S. et al . Evolving guidelines for intravitreous injections. Retina. 2004; 24 S3-S19
- 61 Scott I U, Flynn H W Jr. Reducing the risk of endophthalmitis following intravitreal injections. Retina. 2007; 27 10-12
1 Ein Glossar mit den verwendeten Abkürzungen findet sich am Ende des Textes.
2 Die Mitglieder der Makulakommission finden sich unter http://www.dog.org/dog/kommissionen.html#Makula.