July 2018
Volume 59, Issue 9
ARVO Annual Meeting Abstract  |   July 2018
Effectiveness of ranibizumab for the treatment of patients with diabetic macular edema in a real-world setting: 1- and 2-year results from the LUMINOUS™ study
Author Affiliations & Notes
  • Paul Mitchell
    Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, North Sydney, New South Wales, Australia
  • Soumil Parikh
    Novartis Pharma AG, Basel, Switzerland
  • Wayne Macfadden
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Paul Mitchell, Abbott (C), Abbott (F), Allergan (C), Allergan (F), Bayer (C), Bayer (F), Genentech (C), Genentech (F), Novartis (C), Novartis (F), Roche (C), Roche (F); Soumil Parikh, Novartis (E); Wayne Macfadden, Novartis (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3617. doi:
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      Paul Mitchell, Soumil Parikh, Wayne Macfadden; Effectiveness of ranibizumab for the treatment of patients with diabetic macular edema in a real-world setting: 1- and 2-year results from the LUMINOUS™ study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3617.

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

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Purpose : LUMINOUS (NCT01318941), the largest prospective observational study in retinal medicine, evaluated the long-term effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in clinical practice across all approved indications. Here, we present 1- and 2-year data on effectiveness and safety of ranibizumab treatment in treatment-naïve patients with DME from the final LUMINOUS analysis.

Methods : LUMINOUS (initiated in March 2011) is a recently completed, 5-year, prospective, multicenter, non-interventional, open-label study that enrolled more than 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 approved indications according to local product labels. Data were analyzed by indication and by prior treatment status of the study eye. Reported here are 1-and 2-year visual acuity (VA; primary treated eye) outcomes, injection patterns, adverse events (AEs) and serious AEs (SAEs) for the treatment-naïve DME cohort.

Results : A total of 1,063 treatment-naïve DME patients were recruited worldwide as part of the LUMINOUS study. At baseline, mean (SD) age was 64.5 (11.1) years, 54.7% were male, and 69.2% were Caucasian. In the 502 treatment-naïve DME patients for whom 1-year data were available, mean (SD) VA improved by 3.5 letters (14.6) at 1 year from a baseline of 57.7 letters (18.3) with a mean (SD) of 4.5 (2.5) ranibizumab injections and 8.1 (3.4) monitoring visits. VA gains were greater in patients receiving >4 ranibizumab injections during the year (Figure 1a), particularly in those who received a loading dose of ranibizumab (Figure 1b). Similar to Year 1, VA gains at Year 2 were greater in patients (n=207) who had low baseline VA (Figure 2). Across all treatment-naïve DME patients (N=1,063), the incidence of ocular/non-ocular AEs and SAEs was 7.15%/10.07% and 0.28%/5.83%, respectively. No cases of endophthalmitis were reported.

Conclusions : LUMINOUS confirms both the effectiveness of ranibizumab for the treatment of DME in real-world clinical practice and the importance of administering an adequate number of injections and a loading dose. No new safety signals were identified.

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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