Session Title: Quick Fire Free Paper 4
Session Date/Time: Sunday 14/09/2014 | 08:00-10:00
Paper Time: 08:20
Venue: Boulevard B
First Author: : R.Hamilton UK
Co Author(s): : S. Taylor B. Burton R. Johnston P. Patel J. Warburton C. Brand
The LUMINOUS prospective program is a 5‐year, multicentre, global, observational study initiated to describe the long‐term safety, effectiveness, and treatment patterns associated with ranibizumab 0.5 mg treatment in a broad patient population in routine clinical practice for all approved indications as per the local product label. Understanding usage patterns, clinic visit frequency and associated outcomes may help to optimise patient management. The objectives of this country-level pre-specified interim analysis are to describe these parameters in the first 866 patients from the UK with nAMD who completed 1 year of follow-up.
Patients with nAMD were recruited from ophthalmology clinics in the UK where they received ranibizumab according to local routine clinical practice.
All patients provided written informed consent before any information was collected. Prospective collection of patient demographics, visual acuity, injection frequency, and visit frequency was undertaken on eligible patients. Patients were excluded if involved in any investigational drug or procedure study, and if treated with other VEGF inhibitors in the prior 90 days. The first pre-specified interim analysis occurred in March 2013 after patients enrolled in the first year of recruitment completed one year of follow up. Patients are described according to whether they were treatment naïve (TN) or had received prior treatment with ranibizumab (TP). The UK data are described in the context of the overall global dataset for patients with nAMD. Data are shown as mean±SD in the primary treated eye unless otherwise indicated.
A total of 2112 patients with nAMD were included in the global dataset of whom 866 (41.0%) were from the UK. The demographics of the UK population were comparable to those for the global dataset (Age 79.4±8.22 vs 79.2±8.12 years, Women 61.1% vs 61.8%). TN patients in the UK were younger than TP patients (77.5±9.38 vs 79.6±8.03 years) and time since diagnosis was shorter (median duration 0.03 vs 1.26 years). Baseline visual acuity (VA) in UK patients was lower in TN compared to TP patients (57.3±15.44 vs 59.4±16.32 letters). However, TN in the UK had higher baseline VA compared to global data (57.3±15.44 vs 52.4±20.59 letters). Baseline VA in TP was similar in the UK compared to global (59.4±16.32 vs 60.3±17.89 letters). By 12 months, TN and TP in the UK received 4.6±2.15 and 4.0±3.15 injections compared to 5.2±3.27 and 5.2±3.32 injections, respectively in the global population. TN and TP in the UK underwent 8.0±3.31 and 7.4±3.91 visits during 12 months, similar to global data. At 12 months in the UK, VA in TN was higher than at Baseline (62.6±18.12 letters) and was stable in the TP group (59.6±17.35 letters). Similar observations were evident in the global data.
LUMINOUS includes patients with more diverse demographics than in the pivotal trials and is therefore more representative of real world patients with nAMD. Prior treatment with ranibizumab was associated with higher baseline VA baseline than the treatment naïve group both in the UK and in the global dataset. Patients with nAMD in the UK achieved good visual acuity outcomes at 12 months, irrespective of pre-treatment status, with relatively low numbers of monitoring visits and injections. LUMINOUS is the largest observational study following patients treated for multiple medical retina indications in a clinical practice setting and will provide an invaluable source of long term real world data both globally and for the UK.