Baseline characteristics of 30,000 patients from the final analysis of the real-world LUMINOUS study

Session Details

Session Title: Free Paper Session 3: AMD I

Session Date/Time: Thursday 07/09/2017 | 08:30-10:00

Paper Time: 08:30

Venue: Room 118

First Author: : C.Brand UK

Co Author(s): :    P. Mitchell   M. Figueroa   S. Lacey   W. Macfadden                    

Abstract Details

Purpose:

LUMINOUS™ (NCT01318941) is a recently-completed, five-year, multi-centre, global, observational study 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 real-world setting. Here we present the baseline characteristics of patients from the final analysis of the LUMINOUS study.

Setting:

LUMINOUS, a prospective multicentre non-interventional open-label study (initiated in March 2011), enrolled more than 30,000 patients from 494 sites across 43 countries.

Methods:

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 analysed 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. At baseline, the mean age of patients with nAMD, DME, BRVO, CRVO, mCNV was 77.4, 64.1, 69.4, 69.7, 58.4 years, respectively The majority of the enrolled patients were Caucasians (74.0%-87.9%). The mean baseline best-corrected visual acuity for treatment-naïve patients with nAMD/DME/BRVO/CRVO/mCNV was 49.7/56.3/52.0/40.6/50.8 letters, respectively; while that for patients previously treated with ranibizumab was higher: 56.5/59.3/58.7/49.5/58.0 letters, respectively. The following co-morbidity variations were found at baseline across all five sub-groups; hypertension (35.3–68.1%), diabetes (9.8–99.5%), hypercholesterolemia (20.5–45.4%), and myocardial infarction (3.4–8.3%).

Conclusions:

LUMINOUS, the largest ever study in medical retina included patients from routine clinical practice with more diverse demographics, ocular baseline characteristics, and comorbidities unlike randomised controlled trials, in which difficult to treat patients are excluded. The data from the LUMINOUS study will provide long-term evidence on the use of ranibizumab in the real-world setting and may guide physicians in making treatment decisions to optimise patient outcomes with ranibizumab treatment.

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