Ranibizumab in patients with neovascular age-related macular degeneration in real-world clinical settings in France: 1-year data from the LUMINOUS™ study

Abstract

Purpose : LUMINOUS™ (NCT01318941; initiated March 2011) is the largest, prospective, observational, global study in the field of medical retina. LUMINOUS™ is an ongoing 5-year study that is designed to evaluate the long-term safety, effectiveness, treatment patterns, and health-related quality of life associated with ranibizumab (RBZ) 0.5 mg treatment across all approved indications in 30,000 patients from routine clinical practice. We present the 1-year data from the French patients included in LUMINOUS™.

Methods : Overall, 17, 545 adult patients with neovascular age-related macular degeneration (nAMD) were enrolled before March 2014; of these 9125 adult nAMD patients with a potential for 1-year follow-up were enrolled before March 2013. We analyzed the baseline characteristics of nAMD patients that were enrolled in France before March 2014 and the 1-year data from the French cohort.

Results : Baseline characteristics of the French and the global nAMD cohorts are shown in Table 1. Both the French and the global cohorts had similar mean baseline visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letter score; French/global nAMD cohorts: VA, 58.6/54.3). A higher proportion of patients in the French cohort had pigment epithelium detachment (PED) than those in the global cohort (68.0% versus 42.4%). In the global cohort, the 1-year data showed that on average treatment-naïve patients gained VA from baseline whilst those previously treated with RBZ either gained or maintained VA, with a relatively low number of injections and visits (Table 2). The 1-year data for the French cohort are expected in February 2016.

Conclusions : The French nAMD patients enrolled in the LUMINOUS™ study were slightly older and had similar baseline VA, a higher proportion had PED, and a similar proportion had non-ocular comorbidities at baseline compared with the global nAMD cohort. The 1-year follow-up data from the French cohort will provide an invaluable source of information from a diverse group of patients currently underrepresented in randomized clinical trials.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Table 1. Baseline characteristics of the French and the global nAMD patients enrolled before March 2014

 

Table 2. Outcomes at Year 1 of the global nAMD patients enrolled before March 2013