Purpose
LUMINOUS is a 5-year, global, prospective, observational, long-term study being conducted to evaluate the safety and effectiveness of ranibizumab 0.5 mg in patients with age-related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein oclusion (RVO) in routine clinical practice, treated in accordance with the local product label
Methods
The study aims to enrol 30,000 patients from approximately 500 centres in 34 countries worldwide. Here we report the baseline characteristics of the first cohort of patients enrolled from March 2011 to February 2012
Results
A total of 1915 patients in this recruitment period were included in the analysis. Since majority of the patients (n=1877) have neovascular (n) AMD, here we report the baseline characteristics of nAMD patients. The mean age of these patients is 79.2 years, 61.7% are female, and 93.0% are Caucasian. Demographic characteristics such as age, gender and race are well-balanced between treatment-naïve (T1) and treatment non-naive (T2) groups. Fifty-eight percent of patients are treatment non-naive; median time since nAMD diagnosis to baseline is 0.9 years for T1 patients and 1.9 years for T2 patients. At baseline, mean visual acuity was 55.8 (T1) and 57.7 (T2) letters and central retinal thickness was 283.0 (T1) and 251.0 (T2) µm. Overall, 31.0% of patients had predominantly classic type of lesion, 42.0% had pigment epithelium detachment, 2.2% had polypoidal choroidal vasculopathy and 3.1% had retinal angiomatomous proliferation at baseline
Conclusions
LUMINOUS trial is successfully enrolling patients (more than 7726 patients recruited by Dec, 2012), and the overall baseline characteristics are as expected in a real-world setting
Keywords: 412 age-related macular degeneration •
754 visual acuity