September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Baseline characteristics and 1-year outcomes of patients with neovascular age-related macular degeneration from the real-world LUMINOUS study: global results vs Australian cohort
Author Affiliations & Notes
  • Robyn H Guymer
    Centre for Eye Research Australia, East Melbourne, Victoria, Australia
    Department of Surgery Victoria, Ophthalmology, University of Melbourne, Melbourne, Victoria, Australia
  • Wayne Macfadden
    Ophthalmology, Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Robyn Guymer, Bayer (C), Bayer (R), Novartis (C), Novartis (R); Wayne Macfadden, Novartis Pharma AG, Basel, Swaitzerland (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 531. doi:
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      Robyn H Guymer, Wayne Macfadden; Baseline characteristics and 1-year outcomes of patients with neovascular age-related macular degeneration from the real-world LUMINOUS study: global results vs Australian cohort. Invest. Ophthalmol. Vis. Sci. 2016;57(12):531.

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

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Abstract

Purpose : LUMINOUS (NCT01318941), the largest prospective observational trial in medical retina, is designed to evaluate the long-term safety, effectiveness, treatment patterns, and health-related quality-of-life associated with ranibizumab treatment in clinical practice across all licensed indications. Here we describe baseline characteristics and 1-year outcomes of treatment naïve patients from the global and Australian cohorts with neovascular age-related macular degeneration (nAMD), recruited before March 2014 in the LUMINOUSTM study.

Methods : Patients were treated according to the local product label, and data were analyzed based on prior treatment status of the primary treated eye (treatment naïve, prior ranibizumab treated, or other prior ocular treated). We report the results on treatment naïve patients only.

Results : A total of 17,656 patients with nAMD were recruited, including 1,694 patients from Australia. Of the global and Australian cohorts, 4497 and 227 patients, respectively, were treatment naïve. The baseline characteristics of the Australian patients were similar to the global group in terms of age and sex (Table). The mean age of the global/Australian cohorts was 75.0/79.3 years and 44.2%/44.1% were male. The global cohort had 68.8% of Caucasians whereas it was 91.2% in the Australian cohort. In the global/Australian cohorts, pigment epithelium detachment was present in 41.6%/25.6% of patients and polypoidal choroidal vasculopathy was present in 8.4%/3.1% of patients. At baseline, for global/Australian cohorts, the mean visual acuity (VA, letters) was 49.9/52.9 and the mean central retinal thickness (CRT, µm) was 360.6/300.6. At 1 year, in global/Australian cohorts, the mean change in VA was 3.6/5.3 with a mean of 4.3/7.9 ranibizumab injections and 7.3/9.4 visits. No new safety events were reported in these cohorts.

Conclusions : Overall, treatment naïve patients from the Australian cohort had higher VA and lower CRT at baseline than the global cohort. At 1 year, compared with the global cohort, better VA outcomes were achieved in the Australian cohort, with a higher mean number of injections. Safety findings were consistent with the well-established safety profile of ranibizumab. Future follow-up data from this and other cohorts will provide long-term evidence on ranibizumab treatment outcomes.

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

 

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