Session Title: AMD I
Session Date/Time: Thursday 17/09/2015 | 08:30-10:30
Paper Time: 10:14
First Author: : E.Souied FRANCE
Co Author(s): : S. Lacey
PURPOSE:Although the efficacy and safety profile of ranibizumab have been established in many randomized controlled trials (RCTs), there is limited information on the use of ranibizumab in diverse patient populations in real-life clinical practice.
LUMINOUS™ is the largest prospective observational trial in medical retina, including a diverse range of patients from a large number of geographies under-represented in RCTs. The purpose of this analysis is to describe the baseline characteristics of 17,546 patients with neovascular age-related macular degeneration (nAMD) across multiple countries recruited prior to March 2014.
The ongoing LUMINOUS™ study is a prospective, 5-year, global, observational study designed to evaluate the long-term safety, effectiveness, treatment-patterns and health-related quality-of-life associated with ranibizumab treatment in clinical practice. LUMINOUS™ has reached the target enrolment of 30,000 patients, spanning 550 sites in 45 countries.
Consenting adult patients, treatment naïve, previously or currently being treated with ranibizumab were enrolled for indications as per the local label. Exclusion criteria were simultaneous participation in another investigational study, or systemic/ocular vascular endothelial growth factor (VEGF) inhibitor administration (other than ranibizumab) in the 90 days prior to study enrolment. This was amended to 30 days for ocular anti-VEGFs from January 2014. All analyses of baseline characteristics were divided according to prior-ocular-treatment-history subgroups, defined by the primary treated eye. The subgroups were: T1) treatment-naïve, T2) prior ranibizumab treatment or T3) other prior ocular treatment. A total of 20,085 patients were recruited prior to March 2014, of whom, 17,546 had nAMD; 4,645 in T1, 12,586 in T2, and 315 in T3. In this interim analysis, patient characteristics for the global population are described in addition to country-specific analysis from countries (17 in total) that contributed ≥ 100 nAMD patients. Of these countries, 12 contributed ≥ 100 patients to T1 and 16 contributed ≥ 100 patients to T2 and were included in further analysis of ocular disease characteristics. Due to the small number of patients in T3, they were not included in this analysis.
Mean age for the global population was 77.4 years (23.5% >=85yrs), 58% were female. Baseline mean visual acuity (VA, ETDRS letters) was 48.8 and 56.4 for T1 and T2, respectively. Overall 41.7% of the global population had pigment epithelium detachment (PED), 8.2% had polypoidal choroidal vasculopathy (PCV) and 3.9% had retinal angiomatomous proliferation (RAP). At a country-specific level, heterogeneity was observed for baseline demographics and ocular disease characteristics. Mean age ranged from 68.7 years (China) to 80.2 years (France) with percentage of patients over 85yrs ranging from 3.2% (Russia) to 32.4% (France). Male/female ratio ranged from 28.5/71.5% (Ireland) to 69.8/30.2% (Japan). There were also significant differences in baseline VA between countries: T1 VA ranged from 33.8 letters (Argentina) to 58.7 letters (Japan). In all countries analysed, baseline VA for T2 was higher than T1 and ranged from 38.2 letters (Argentina) to 62.1 letters (Ireland). Median time between diagnosis and treatment for T1 ranged from 0.16 weeks (Canada, Poland, Germany, South Korea) to 18.2 weeks (Argentina). The incidence of PED ranged from 18.8% (Canada) to 71.8% (South Korea). The incidence of PCV and RAP ranged from 0% (Hungary) to 33.6% (South Korea) and 0% (Germany) to 8.3% (Japan), respectively.
LUMINOUS™ includes patients with more diverse demographics than observed in controlled pivotal trials. The baseline characteristics of these patients represent those observed in a real-world setting and range widely across distinct geographies. These findings emphasise the value of real world evidence, and also highlight the value of inter-country analysis in global studies. To inform best clinical practice, it is important to determine how a treatment may perform in different clinical settings in the real world and outside of the rigorous experimental design of RCTs. Future follow-up data from LUMINOUS™ on a country by country basis will provide an invaluable source of information from diverse geographies, many of which are currently under-represented in RCTs.