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

Purpose The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age‐related macular degeneration (wet AMD) in daily practice. Met...

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Bibliographic Details
Published in:	Acta ophthalmologica (Oxford, England) Vol. 93; no. 2; pp. 126 - 133
Main Authors:	Asten, Freekje, Evers‐Birkenkamp, Kim U., Lith‐Verhoeven, Janneke J. C., Jong‐Hesse, Yvonne, Hoppenreijs, Vincent P. T., Hommersom, Richard F., Scholten, Agnes M., Hoyng, Carel B., Klaver, Johannes H. J.
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01-03-2015
Subjects:	Aged Aged, 80 and over Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects daily practice Female Humans Intravitreal Injections Macular degeneration Male Medical research neovascular AMD observational Ophthalmology Prospective Studies quality of life Quality of Life - psychology Questionnaires Ranibizumab Sickness Impact Profile Surveys and Questionnaires Tomography, Optical Coherence Treatment Outcome Vascular Endothelial Growth Factor A - antagonists & inhibitors Vision Disorders - prevention & control visual acuity Visual Acuity - physiology Wet Macular Degeneration - drug therapy Wet Macular Degeneration - physiopathology Wet Macular Degeneration - psychology visual acuity observational daily practice quality of life neovascular AMD ranibizumab
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Summary:	Purpose The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age‐related macular degeneration (wet AMD) in daily practice. Methods The HELIOS study was a 2‐year prospective, observational, open‐label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time‐points 3, 6, 12, 18 and 24 months after inclusion. Results Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ‐5D questionnaire, which did not significantly change over the study period. The more subjective EQ‐VAS questionnaire showed an overall improvement. The VFQ‐25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long‐term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. Conclusion This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Undefined-2
ISSN:	1755-375X 1755-3768
DOI:	10.1111/aos.12610