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Posters

Baseline characteristics of over 10,000 patients enrolled in the LUMINOUS study- ranibizumab in a real world setting

Poster Details

First Author: C.Brand UK

Co Author(s):                      0   0 0   0 0   0 0   0 0

Abstract Details



Purpose:

Ranibizumab 0.5mg is approved for the treatment of wet age-related macular degeneration(wAMD), and visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), and choroidal neovascularization secondary to pathologic myopia in many countries worldwide. The efficacy and safety profile of ranibizumab in clinical trials has been well-characterized and is supported by >2.4 million patient-treatment years of exposure. However, long-term safety and effectiveness has not been systematically studied in clinical practice. The LUMINOUS study (NCT01318941) is designed to assess the long-term safety, effectiveness, treatment-patterns and health-related-quality-of-life associated with ranibizumab treatment in a real world setting

Setting:

LUMINOUS is an ongoing 5-year, observational, multicenter study aiming to enroll 30,000 patients treated with ranibizumab for any approved indication included in the local product label, from 600 sites in 41 countries. Here, we describe the baseline characteristics of the first 10,071 patients recruited in this study

Methods:

Consenting adult patients (treatment naïve or previously treated with ranibizumab or other ocular treatments) were enrolled. Exclusion criteria were simultaneous participation in another investigational study, or systemic/ocular vascular endothelial growth factor (VEGF) inhibitor administration (other than ranibizumab) within 90 days prior to study enrolment. The study does not direct therapy or recommend any treatment other than patients be treated in accordance with the local product label for ranibizumab. Timings of patient visits and ranibizumab injections were at the discretion of the treating physician. Here we report the baseline demographic, ocular disease characteristics and key non-ocular comorbidities of these patients

Results:

As of February 2014, >21,000 patients had been recruited to the study, with baseline data available for 10,071 patients (wAMD: n=9376; DME: n=454; branch retinal vein occlusion [BRVO]: n=124; central retinal vein occlusion [CRVO] n=117). A total of 1891 (18.8%) were treatment naïve (T1), 7914 (78.6%) had prior ranibizumab treatment (T2), and 266 (2.6%) had received other ocular treatments prior to enrolment (T3). Pre-treatment status was defined by the primary treated eye. The majority of enrolled patients were Caucasian (82.3-94.0%) with a mean age of 78.8/64.4/69.4/67.6 years in wAMD/DME/BRVO/CRVO, respectively. The non-ocular comorbidities reported in the LUMINOUS study population (wAMD/DME/BRVO/CRVO, %) were myocardial infarction (9.0/7.7/1.6/5.1), stroke (6.3/7.3/5.6/6.0), family history of coronary heart disease (19.6/16.5/17.7/13.7), hypertension (60.7/64.3/58.1/61.5), and hypercholesterolemia/lipidemia (36.6/39.0/25.8/27.4). The baseline mean visual acuity (VA, ETDRS letter score) of the study eye was numerically higher in T2 than T1 across all indications (wAMD: 55.6/46.4 letters; DME: 55.3/40.8 letters; BRVO: 52.9/37.3 letters; CRVO: 45.2/38.9 letters). The baseline mean central retinal thickness (CRT) was lower in T2 than T1 across all indications (wAMD: 265.6/347.3μm; DME: 371.5/429.3μm; BRVO: 328.8/456.5μm; CRVO: 365.9/555.4μm)

Conclusions:

The LUMINOUS study includes real world patients from clinical practice and thus characterizes a more diverse demographic than reported in the controlled pivotal trials. Across all indications at baseline, prior ranibizumab treatment was associated with numerically higher VA and lower CRT baseline values than the treatment naïve group. The LUMINOUS study will provide a valuable source of both safety and effectiveness data for the use of ranibizumab in clinical practice

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