September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
One-year outcomes with ranibizumab in treatment naïve patients with neovascular age-related macular degeneration: an interim analysis from the LUMINOUS™ study
Author Affiliations & Notes
  • Christopher Brand
    Royal Hallamshire Hospital, Sheffield, United Kingdom
  • Sue Lacey
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Christopher Brand, Alcon (F), Allergan (F), Allergan (C), Bayer (C), Novartis Pharmaceuticals (F), Novartis Pharmaceuticals (C), Novartis Pharmaceuticals (R), Oraya (C), Oraya (R), Oraya (F), Pfizer (C), Pfizer (R), Roche (F); Sue Lacey, Novartis Pharma AG (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 515. doi:
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    • Get Citation

      Christopher Brand, Sue Lacey; One-year outcomes with ranibizumab in treatment naïve patients with neovascular age-related macular degeneration: an interim analysis from the LUMINOUS™ study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):515.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : LUMINOUS™ (NCT01318941) is an ongoing, 5-year, multicenter, global, observational study, designed to evaluate the long-term safety, effectiveness, treatment patterns, and health-related quality of life outcomes associated with ranibizumab treatment in routine clinical practice across all approved indications. Here we present baseline characteristics and visual outcomes of treatment naïve patients from a cohort of 17656 patients with neovascular age-related macular degeneration (nAMD) enrolled before March 2014 and who had the potential for 1-year follow-up, from the third interim analysis of LUMINOUS™.

Methods : Consenting adult (≥18 years) nAMD patients, who were treatment naïve or previously treated with ranibizumab or other ocular treatments were enrolled and treated as per the local label. This analysis focuses on injection patterns in the study eye of treatment naïve patients.

Results : Of the 43 countries participating in the study, the highest number of patients with nAMD were enrolled from the United Kingdom (n=7350) followed by Australia (n=1694), Canada (n=1632), Poland (n=567), and Russia (n=561). Of the total 17656 patients enrolled with nAMD, 4497 were treatment naïve. The mean age of treatment naïve patients was 75.0 years; 68.8% were Caucasian, 55.8% were female. In treatment naïve patients, at baseline, the mean visual acuity (VA) was 49.9 letters, and the mean central retinal thickness was 360.6 µm. At 1 year, the mean change in VA from baseline was 3.6 letters with a mean of 4.3 injections and 7.3 visits. The VA gains in treatment naïve patients receiving <3, 3–6, and >6 injections were 2.4 letters, 3.5 letters, and 4.5 letters, respectively (Figure). Those patients receiving >6 injections including 3 loading doses of ranibizumab within the first 90 days of treatment gained 5.3 letters at 1 year from a baseline of 55.5 letters. Safety findings in treatment naïve patients were consistent with the well-established safety profile of ranibizumab.

Conclusions : At 1 year, treatment naïve patients had substantial improvement in VA with ranibizumab treatment. Future follow-up data and country-level analyses from the LUMINOUS™ study will provide invaluable information to optimize patient outcomes with ranibizumab treatment.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

VA, stratified by injection frequency at 1 year in treatment naïve patients

VA, stratified by injection frequency at 1 year in treatment naïve patients

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