Session Title: Free Paper Session 16: Vascular Diseases & Diabetic Retinopathy IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 16:36
Venue: Room 114
First Author: : P.Mitchell AUSTRALIA
Co Author(s): : F. Ziemssen T. Sheidow S. Parikh W. Macfadden
Diabetic macular edema (DME) is the most frequent cause of vision loss in patients with diabetic retinopathy. Ranibizumab is approved for the treatment of visual impairment secondary to DME but limited data are available on its use in real-world settings. LUMINOUS™ (NCT01318941), the largest prospective observational study in the medical retina field, evaluated the long-term safety, effectiveness, and treatment patterns associated with ranibizumab 0.5 mg treatment in routine clinical practice across all approved indications. Here we present the effectiveness and safety of ranibizumab treatment in patients with DME from the final analysis of the LUMINOUS study.
LUMINOUS (initiated in March 2011) is a recently completed, 5-year, global, multicentre, observational, non-interventional, open-label study, that recruited over 30,000 patients from 494 sites in 43 countries. All patients were treated as per the local practice of the participating centres.
Consenting adult patients (≥18 years), who were either treatment-naïve, previously treated with ranibizumab or another ocular therapy, were recruited for all approved indications (neovascular age-related macular degeneration, DME, branch and central retinal vein occlusion, and myopic choroidal neovascularization) as per the local label. Patients were excluded if participating in other investigational studies or if they had received systemic or ocular anti-vascular endothelial growth factor therapy other than ranibizumab, 90 days or 30 days prior to recruitment, respectively. The study was conducted in accordance to the Declaration of Helsinki and Good Clinical Practice guidelines, and approved by the Ethics Committee or Institutional Review Board at each participating centre. Analyses were conducted according to patient subgroups: treatment-naïve, prior ranibizumab treatment and other prior ocular treatment. Here, we report, for the treatment-naïve DME patient subgroup, the change in VA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter score, primary treated eye) over the first year of treatment, as well as the change in VA stratified by the number of injections patients received (<3, 3–6, and >6 injections). The incidence of ocular and non-ocular adverse events (AEs) and serious AEs (SAEs) for the total treatment-naïve DME cohort is also presented.
One year VA data are available for 375 treatment-naïve DME patients. At baseline, the mean age of DME patients was 64.3 years; 54.4% of patients were male; 74.4% of patients were Caucasian, and 10.4% were Asian. VA gains at 1 year in treatment-naïve patients receiving <3, 3–6, and >6 injections were 1.2 letters (n=80), 3.9 letters (n=199), and 5.6 letters (n=96), from baseline letter scores of 50.3, 60.7, and 59.8 letters, respectively. The mean change in VA across all injection categories and across all global regions and health care systems was +3.8 letters from a mean baseline VA of 58.2 letters, achieved with a mean of 4.8 ranibizumab injections and 8.7 mean visits. Ocular and non-ocular SAEs reported in treatment-naïve DME patients (n=1,063) were 0.28% and 5.83%, respectively. Ocular and non-ocular AEs were reported in 7.15% and 10.06% of treatment-naïve DME patients, respectively.
The LUMINOUS study includes DME patients with more diverse baseline characteristics than those in randomized clinical trials. The 1 year data from the real-world LUMINOUS study demonstrate improvement VA with a relatively low number of injections and moderate number of visits in treatment-naïve patients with DME. Greater VA gains were noted in patients with 3-6 injections, with the best results in patients who received at least 6 injections. No new safety findings were identified. These results from the final analysis of LUMINOUS demonstrate the effectiveness and safety of ranibizumab for the treatment of DME in real-world clinical practice.