July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Baseline characteristics of the 30,000 patients enrolled in LUMINOUS™, a real-world study with ranibizumab
Author Affiliations & Notes
  • Christopher Brand
    Royal Hallamshire Hospital, Sheffield, United Kingdom
  • Soumil Parikh
    Novartis Pharma AG, Basel, Switzerland
  • Wayne Macfadden
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Christopher Brand, Bayer (C), Bayer (F), Novartis (C), Novartis (F), Oraya (C), Oraya (F); Soumil Parikh, Novartis (E); Wayne Macfadden, Novartis (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3902. doi:
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      Christopher Brand, Soumil Parikh, Wayne Macfadden; Baseline characteristics of the 30,000 patients enrolled in LUMINOUS™, a real-world study with ranibizumab. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3902.

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

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Abstract

Purpose : LUMINOUS (NCT01318941) was designed to evaluate the long-term effectiveness, safety, and treatment patterns associated with ranibizumab treatment in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV) in the real-world setting. Here we present the baseline characteristics of patients from the final analysis of the LUMINOUS study.

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 the approved indication according to the local product label. Data were analyzed by indication and by prior treatment status of the study eye.

Results : Baseline data are available for 30,138 patients of whom, 22,717 had nAMD; 4,710 had DME; 2,414 had RVO (branch RVO [BRVO]/central RVO [CRVO]; 1,366/1,048) and 297 had mCNV. Demographics and baseline ocular characteristics varied between indications (Table). The patients with nAMD were the oldest and those with mCNV were the youngest. The majority of the enrolled patients were Caucasian (range: 74.0%–87.9%). Pigment epithelium detachment (42%) was the most common nAMD subtype followed by polypoidal choroidal vasculopathy (7%) and retinal angiomatous proliferation (3%). The mean baseline visual acuity was highest in patients with DME (57.8 letters) and lowest in those with CRVO (44.7 letters). The proportion of patients with comorbidities also varied across all five indications (Figure); hypertension, diabetes, and hypercholesterolemia were more prevalent in this population compared with randomized clinical trials (RCTs).

Conclusions : LUMINOUS, the largest ever study in medical retina, included patients from routine clinical practice with diverse demographics, ocular baseline characteristics, and with no restriction on comorbidities, unlike RCTs. This baseline data analysis may be useful to better inform treatment practices and improve visual and quality of life outcomes for nAMD, DME, RVO, and mCNV patients.

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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