A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration

Acta Ophthalmologica

Volumn 93, Issue 2, 2015, Pages 126-133

  Van Asten, Freekje ^a   Evers Birkenkamp, Kim U ^b   Van Lith Verhoeven, Janneke J C ^c   De Jong Hesse, Yvonne ^d   Hoppenreijs, Vincent P T ^e   Hommersom, Richard F ^f   Scholten, Agnes M ^g   Hoyng, Carel B ^a   Klaver, Johannes H J ^g  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b Novartis Pharma BV   (Netherlands)

^c CPRLab   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e DEVENTER HOSPITAL   (Netherlands)

^f MÁXIMA MEDICAL CENTER   (Netherlands)

^g OMC Haarlem   (Netherlands)

Author keywords

daily practice; neovascular AMD; observational; quality of life; ranibizumab; visual acuity

Indexed keywords

RANIBIZUMAB; ANGIOGENESIS INHIBITOR; MONOCLONAL ANTIBODY; VASCULOTROPIN A; VEGFA PROTEIN, HUMAN;

AGE RELATED MACULAR DEGENERATION; AGED; ARTICLE; CATARACT; CEREBROVASCULAR ACCIDENT; CHOROID HEMORRHAGE; CLINICAL PRACTICE; CONJUNCTIVAL HEMORRHAGE; CONTROLLED STUDY; DETERIORATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; EARLY TREATMENT OF DIABETIC RETINOPATHY STUDY SCORE; EYE DISEASE; EYE PAIN; FEMALE; HEART DEATH; HEART DISEASE; HEART INFARCTION; HEART SURGERY; HUMAN; INTRAOCULAR PRESSURE ABNORMALITY; IRIS BOMBE; IRIS DISEASE; LUNG METASTASIS; MAJOR CLINICAL STUDY; MALE; NATIONAL EYE INSTITUTE VISUAL FUNCTION QUESTIONNAIRE 25; OBSERVATIONAL STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PERIPHERAL VISION; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; QUESTIONNAIRE; RATING SCALE; RETINA DETACHMENT; RETINA TEAR; SCORING SYSTEM; SIDE EFFECT; SOCIAL INTERACTION; STOMACH CANCER; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL ACUITY; VISUAL ANALOG SCALE; VISUAL IMPAIRMENT; VITREOUS FLOATERS; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; INTRAVITREAL DRUG ADMINISTRATION; MULTICENTER STUDY; OPTICAL COHERENCE TOMOGRAPHY; PATHOPHYSIOLOGY; PHYSIOLOGY; PSYCHOLOGY; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME; VERY ELDERLY; VISION DISORDERS; WET MACULAR DEGENERATION;

AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; FEMALE; HUMANS; INTRAVITREAL INJECTIONS; MALE; PROSPECTIVE STUDIES; QUALITY OF LIFE; QUESTIONNAIRES; SICKNESS IMPACT PROFILE; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VISION DISORDERS; VISUAL ACUITY; WET MACULAR DEGENERATION;

EID: 84923257139     PISSN: 1755375X     EISSN: 17553768     Source Type: Journal    
DOI: 10.1111/aos.12610     Document Type: Article

References (29)

1. Abraham P, Yue H, &, Wilson L, (2010): Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2. Am J Ophthalmol 150: 315-324.
2. Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, &, Rubio RG, (2009): A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology 116: 1731-1739.
3. Brown MM, Brown GC, Stein JD, Roth Z, Campanella J, &, Beauchamp GR, (2005): Age-related macular degeneration: economic burden and value-based medicine analysis. Can J Ophthalmol 40: 277-287.
4. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T, & ANCHOR Study Group (2009): Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology 116: 57-65.
5. Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, Reeves BC, & IVAN Study Investigators (2013): Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet 382: 1258-1267.
6. Chen Y, Wiesmann C, Fuh G, Li B, Christinger HW, McKay P, de Vos AM, &, Lowman HB, (1999): Selection and analysis of an optimized anti-VEGF antibody: crystal structure of an affinity-matured Fab in complex with antigen. J Mol Biol 293: 865-881.
7. Cohen SY, Mimoun G, Oubraham H, Zourdani A, Malbrel C, Quere S, Schneider V, & LUMIERE Study Group (2013): Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the LUMIERE study. Retina 33: 474-481.
8. Congdon N, O'Colmain B, Klaver CC, et al. (2004): Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol 122: 477-485.
9. Dadgostar H, Ventura AA, Chung JY, Sharma S, &, Kaiser PK, (2009): Evaluation of injection frequency and visual acuity outcomes for ranibizumab monotherapy in exudative age-related macular degeneration. Ophthalmology 116: 1740-1747.
10. Finger RP, Wiedemann P, Blumhagen F, Pohl K, &, Holz FG, (2013): Treatment patterns, visual acuity and quality-of-life outcomes of the WAVE study-a noninterventional study of ranibizumab treatment for neovascular age-related macular degeneration in Germany. Acta Ophthalmol 91: 540-546.
11. Friedman DS, O'Colmain BJ, Munoz B, et al. & (2004): Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol 122: 564-572.
12. Gerding H, Loukopoulos V, Riese J, Hefner L, &, Timmermann M, (2011): Results of flexible ranibizumab treatment in age-related macular degeneration and search for parameters with impact on outcome. Graefe Arch Clin Exp Ophthalmol 249: 653-662.
13. Gregori NZ, Feuer W, &, Rosenfeld PJ, (2010): Novel method for analyzing snellen visual acuity measurements. Retina 30: 1046-1050.
14. Gupta B, Adewoyin T, Patel SK, &, Sivaprasad S, (2011): Comparison of two intravitreal ranibizumab treatment schedules for neovascular age-related macular degeneration. Br J Ophthalmol 95: 386-390.
15. Holz FG, Amoaku W, Donate J, et al. (2011): Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study. Ophthalmology 118: 663-671.
16. Holz FG, Bandello F, Gillies M, et al. (2013): Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme. Br J Ophthalmol 97: 1161-1167.
17. Lala C, Framme C, Wolf-Schnurrbusch UE, &, Wolf S, (2013): Three-year results of visual outcome with disease activity-guided ranibizumab algorithm for the treatment of exudative age-related macular degeneration. Acta Ophthalmol 91: 526-530.
18. Martin DF, Maguire MG, Fine SL, et al. (2012): Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 119: 1388-1398.
19. Mitchell P, Korobelnik JF, Lanzetta P, Holz FG, Prunte C, Schmidt-Erfurth U, Tano Y, &, Wolf S, (2010): Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials. Br J Ophthalmol 94: 2-13.
20. Pascolini D, Mariotti SP, Pokharel GP, Pararajasegaram R, Etya'ale D, Negrel AD, &, Resnikoff S, (2004): 2002 global update of available data on visual impairment: a compilation of population-based prevalence studies. Ophthalmic Epidemiol 11: 67-115.
21. Querques G, Azrya S, Martinelli D, et al. (2010): Ranibizumab for exudative age-related macular degeneration: 24-month outcomes from a single-centre institutional setting. Br J Ophthalmol 94: 292-296.
22. Rakic JM, Leys A, Brie H, et al. (2013): Real-world variability in ranibizumab treatment and associated clinical, quality of life, and safety outcomes over 24 months in patients with neovascular age-related macular degeneration: the HELIOS study. Clin Ophthalmol 7: 1849-1858.
23. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY, & MARINA Study Group (2006a): Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 355: 1419-1431.
24. Rosenfeld PJ, Rich RM, &, Lalwani GA, (2006b): Ranibizumab: phase III clinical trial results. Ophthalmol Clin North Am 19: 361-372.
25. Rothenbuehler SP, Waeber D, Brinkmann CK, Wolf S, &, Wolf-Schnurrbusch UE, (2009): Effects of ranibizumab in patients with subfoveal choroidal neovascularization attributable to age-related macular degeneration. Am J Ophthalmol 147: 831-837.
26. Rotsos T, Patel PJ, Chen FK, &, Tufail A, (2010): Initial clinical experience of ranibizumab therapy for neovascular age-related macular degeneration. Clin Ophthalmol 4: 1271-1275.
27. Schmidt-Erfurth UM, Richard G, Augustin A, et al. (2007): Guidance for the treatment of neovascular age-related macular degeneration. Acta Ophthalmol Scand 85: 486-494.
28. Summary of Product Characteristics Lucentis (2008): http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000715/human-med-000890.jsp&mid=WC0-b01ac058001d124.
29. Wolf A, &, Kampik A, (2014): Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research. Graefe Arch Clin Exp Ophthalmol 252: 647-655.