Session Title: Vascular Diseases and Diabetic Retinopathy IV
Session Date/Time: Sunday 20/09/2015 | 09:00-10:30
Paper Time: 09:56
First Author: : I.Pearce UNITED KINGDOM
Co Author(s): : A. Das Gupta S. Lacey
PURPOSE:Ranibizumab is approved for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion [RVO; branch (BRVO) or central (CRVO)] in many countries worldwide. Although the efficacy and safety profile of ranibizumab have been established in many randomized controlled trials (RCTs), its use in RVO patients in a real-world setting is less well documented. Here, we present the baseline characteristics of BRVO and CRVO patients enrolled before March 2014 and the one-year follow up data for patients enrolled in the LUMINOUS study before March 2013.
The ongoing LUMINOUS™ study is a prospective, 5-year, global, observational trial 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 approved indications. LUMINOUS™ has reached the target enrolment of 30,000 patients, spanning 550 sites in 45 countries.
Consenting adult RVO patients, within age limit as defined by local regulations and local product label, who were treatment naïve, previously or currently being treated with ranibizumab were enrolled. Patients were excluded if participating in another investigational study or if they had received systemic vascular endothelial growth factor (VEGF) inhibitor (other than ranibizumab) in the 90 days prior to study enrolment (or 30 days for ocular anti-VEGFs). 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, 393 had BRVO and 350 had CRVO.
Mean age for BRVO/CRVO patients was 69.0/68.2 years, 54.2/44.0% were female, and 82.7/84.3% were Caucasian. Overall, the baseline mean visual acuity (VA, approximate ETDRS letters, primary treated eye) for BRVO/CRVO was higher in T2 (58.2/49.8) than T1 (52.0/43.1) and T3 (48.5/35.1). 119 patients for each of BRVO/CRVO had the potential for one year of follow up data i.e. had been recruited prior to March 2013. The small number of patients who had both baseline and 12 month visual acuities (BRVO/CRVO) showed mean VA (letters) gains of 7.0/13.2 (n=7/15) in T1 and 8.0/1.4 (n=20/16) in T2. These VA gains were observed with a relatively low mean number of injections and monitoring visits (BRVO/CRVO: T1, 3.6/3.8 injections and 5.8/5.3 monitoring visits; T2, 3.7/3.3 injections and 6.2/5.8 monitoring visits). The rates of ocular and non-ocular serious adverse events for BRVO/CRVO combined were 1.3% and 3.8%, respectively.
The 1-year data showed that on average, ranibizumab treatment led to improvement or maintenance of VA outcomes in RVO patients irrespective of pre-treatment status. These outcomes were achieved with a low mean number of injections and monitoring visits. Future data from subsequent interim analysis with larger patient numbers and potential for inter-country analysis will provide an invaluable source of information for RVO patients.