September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Baseline characteristics and 1-year outcomes of patients with polypoidal choroidal vasculopathy: an interim analysis from the real-world LUMINOUS™ study
Author Affiliations & Notes
  • Adrian H C Koh
    Ophthalmology, Eye & Retina Surgeons, Camden Medical Centre, Singapore, Singapore
  • Ayan Das Gupta
    Novartis Healthcare Private Ltd., Hyderabad, India
  • Philippe Margaron
    Novartis Pharma AG, Basel , Switzerland
  • Sue Lacey
    Novartis Pharma AG, Basel , Switzerland
  • Footnotes
    Commercial Relationships   Adrian H Koh, Allergan (C), Carl Zeiss Meditec (C), Heidelberg Engineering (C), Novartis (C); Ayan Das Gupta, Novartis (E); Philippe Margaron, Novartis (E); Sue Lacey, Novartis (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Adrian H C Koh, Ayan Das Gupta, Philippe Margaron, Sue Lacey; Baseline characteristics and 1-year outcomes of patients with polypoidal choroidal vasculopathy: an interim analysis from the real-world LUMINOUS™ study. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : Ranibizumab (RBZ) is approved for the treatment of neovascular age-related macular degeneration (nAMD). LUMINOUS™ (NCT01318941) is a prospective, observational, 5-year global study designed to evaluate the long-term safety, effectiveness, treatment patterns, and health-related quality of life outcomes associated with ranibizumab treatment in clinical practice across all approved indications. The third interim analysis of LUMINOUS™ evaluated the outcomes of RBZ treatment in patients with polypoidal choroidal vasculopathy (PCV), a subtype of nAMD. We present the baseline characteristics and 1-year results of PCV patients enrolled in this study.

Methods : Patients received RBZ treatment as per the approved local product label. Patients with nAMD were categorized as PCV or non-PCV based on the presence or absence of lesion characteristics as assessed by the study investigator. Data were further analyzed by prior treatment status of the study eye (treatment naïve, T1; prior RBZ treated, T2; and other prior treatment, T3).

Results : Baseline and 1-year follow-up data were available from 1094 PCV (T1, 377; T2, 678; T3, 39) and 16498 non-PCV patients (T1, 4108; T2, 12257; T3, 133) recruited prior to March 2014. The PCV/non-PCV patients had a mean age of 74.0/77.9 years, 44.0%/59.6% were female and 66.0%/13.5% were Asians. Further analyses were performed on T1 and T2 subgroups (>96% PCV and 99% non-PCV patients). Baseline visual acuity (VA) and central retinal thickness (CRT) were similar between PCV and non-PCV patients (Table 1). At 1-year, in the PCV/non-PCV patients, the mean VA improved by +3.0/+3.7 letters, in T1 (n=136/n=1821) while it was maintained in T2 (PCV, -0.6 letters [n=298]; non-PCV, -1.5 letters [n=6365]). Mean reduction in CRT was comparable between PCV and non-PCV patients. These results were achieved with similar mean number of injections and visits, regardless of the PCV status (Table 2). Safety was in line with the overall safety profile in nAMD patients with no new serious adverse events reported.

Conclusions : There was no remarkable difference in treatment outcomes between the PCV and non-PCV patients at 1 year. The results from this analysis suggest that both PCV and non-PCV patients could be treated similarly with ranibizumab.

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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