July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Evolution over 4 years of enrollment of baseline characteristics of treatment-naïve nAMD patients in the LUMINOUS study
Author Affiliations & Notes
  • Eric H Souied
    Hôpital Intercommunal, Hopital Henri Mondor, Paris, France
  • Wayne Macfadden
    Novartis Pharma AG, Basel, Switzerland
  • Soumil Parikh
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Eric Souied, Allergan (C), Bayer (C), Novartis (C), Roche (C), Thea (C); Wayne Macfadden, Novartis Pharma AG (E); Soumil Parikh, Novartis Pharma AG (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 814. doi:
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      Eric H Souied, Wayne Macfadden, Soumil Parikh; Evolution over 4 years of enrollment of baseline characteristics of treatment-naïve nAMD patients in the LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):814.

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

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Abstract

Purpose : Ranibizumab has a well-established efficacy and safety profile for treatment of neovascular age-related macular degeneration (nAMD) based on many randomized controlled trials; its effectiveness has also been demonstrated in real-world studies. LUMINOUS (NCT01318941) evaluated the long-term effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in clinical practice across all approved indications. Here, we preset an analysis on the evolution of baseline characteristics in treatment-naïve nAMD patients, looking at how these changed over four years of enrollment during the LUMINOUS study.

Methods : LUMINOUS is a recently completed, 5-year, prospective, multicenter, non-interventional, open-label study that enrolled over 30,000 patients from 488 sites across 42 countries. Consenting adult (≥18 years) patients who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were enrolled and treated with ranibizumab for the approved indication according to the local product label, and local practices. This analysis examines the change over four years of enrollment in baseline characteristics of treatment-naïve nAMD patients, including mean age, VA, time from diagnosis to first treatment, and lesions.

Results : Enrollment of treatment-naïve nAMD patients increased steadily over time until Year 3, when the highest number was enrolled, then decreased again in Year 4 (Figure 1). When comparing mean baseline age and VA of these patients over the 4 enrollment years (Figure 2), there was a similar overall trend towards decreasing age and VA as the years progressed, except for a slight increase towards the last year. Time to first treatment also showed a similar trend of overall decrease, again with the exception of an increase from Year 3 to 4. Other ocular characteristics, such as proportion with lesions, did not show any apparent trends.

Conclusions : LUMINOUS provides a wealth of real-world evidence on ranibizumab, as well on the large real-world population it enrolled. The changes over the 4 years of enrollment in baseline VA, age and time to treatment from diagnosis in treatment-naïve nAMD patients suggest an association. Further analysis is needed to better understand the precise relationship between these baseline factors, and how they predict VA outcomes with anti-VEGF therapy.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

 

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