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

• 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
• ISSN: 1755-375X; 1755-3768
• DOI: 10.1111/aos.12610

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.