Abstract
Purpose :
LUMINOUS™ (NCT01318941), the largest prospective observational trial in medical retina, is designed to evaluate the long-term safety, effectiveness, treatment patterns, and health-related quality-of-life associated with ranibizumab treatment in clinical practice across all licensed indications. As of June 2015, the study has enrolled 30,514 patients, spanning 494 sites across 43 countries. Here we describe the results from the third interim analysis from the cohort of 285 patients with myopic choroidal neovascularization (mCNV), recruited prior to March 2015.
Methods :
Patients were treated according to the local product label, and the dataset was analyzed by prior treatment status of the primary treated eye (treatment naïve, T1; prior ranibizumab treated, T2; or other prior ocular treated, T3).
Results :
In total, 29,055 patients were recruited prior to March 2015, of whom 285 had mCNV; 95 (33.4%) were T1, 166 (58.2%) were T2, and 24 (8.4%) were T3. Overall, the mean age of patients with mCNV was 58.2 years, 71.0% were female, 87.4% were Caucasian, and 7.4% were Asian. Mean baseline visual acuity (VA) was higher in T2 (58.2) than both T1 (49.8) and T3 (47.1). The baseline characteristics of patients with mCNV in this real-world study were comparable to those of the phase III RADIANCE study (NCT01217944) (Table). Median time from diagnosis of mCNV to first ranibizumab treatment/study entry was 0.01, 1.19, and 1.37 years for T1, T2, and T3, respectively. Baseline comorbidities included hypertension (33.7% of patients), obesity (14.0%), diabetes (8.8%), history of myocardial infarction (3.5%), and history of stroke (2.5%).
Conclusions :
LUMINOUS™ has included patients with mCNV from 23 countries across Europe, Asia, South America, and Canada; many of these are currently under-represented in randomized controlled trials. The baseline characteristics of patients with mCNV in LUMINOUS™ are similar to those enrolled in the phase III RADIANCE study, supporting the generalizability of the results of this registration study to other mCNV populations. At baseline, patients previously treated with ranibizumab had better VA than those who were treatment naïve or who had previously received other ocular treatments. Future follow-up data from the mCNV cohort will provide long-term evidence on ranibizumab treatment outcomes in real-world clinical practice.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.