Session Title: Vascular Diseases III
Session Date/Time: Sunday 29/09/2013 | 08:00-10:00
Paper Time: 08:00
Venue: Hall 3 (Level 0)
First Author: N.Tan SINGAPORE
Co Author(s): T. Wong T. Ishibashi K. Ohno-Matsui J. Petrillo
Choroidal neovascularization (CNV) secondary to pathological myopia may result in substantial central visual impairment, and verteporfin photodynamic therapy (vPDT) is currently the only approved drug treatment. However, anti-vascular endothelial growth factor therapies have been reported to provide rapid and sustained visual improvement in patients with CNV secondary to pathological myopia. RADIANCE (Ranibizumab And PDT [verteporfIn] evAluation iN myopic Choroidal nEovascularization) is a randomized controlled trial of efficacy and safety of two different dosing regimens of ranibizumab 0.5 mg versus vPDT. We report the change in patient-reported visual function scores using the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)
A global, multicentre, phase 3, randomized, double-masked, active-controlled, 12-month trial involving centres across Europe, North America, India and East Asia.
Patients were randomized to one of three groups: two initial monthly ranibizumab injections with subsequent retreatment based on visual acuity criteria (“stabilization” group, n = 105); one initial ranibizumab injection with subsequent retreatment based on optical coherent tomography or fluorescein angiography features (“disease activity” group, n = 116); or vPDT (“vPDT” group, n = 55). From month 3, patients originally assigned to vPDT could receive ranibizumab. The NEI VFQ-25 was administered in local languages at baseline, 3 months, 6 months and 12 months to measure patient-reported visual functioning. Initial results from an exploratory analysis (including descriptive P values without adjustment for multiple testing) are reported using last observation carried forward analysis. Results are expressed as mean change from baseline.
The mean baseline NEI VFQ-25 composite score was 69.3, 71.0 and 71.9 in the stabilization, disease activity and vPDT groups, respectively. From baseline to month 3, the increase in score was greater in the stabilization (5.3 points, P = 0.047) and disease activity (4.3 points, P = 0.045) groups compared with the vPDT group (0.3 points). The 0–3 month increase in near activities score was 11.5 points (P = 0.005) and 5.3 points (P = 0.138) in the stabilization and disease activity groups compared with 0.9 points in the vPDT group. Mental health scores increased by 7.4 points (P = 0.018) and 4.9 points (P = 0.046) in the stabilization and disease activity groups compared with a decrease of 1.8 points in the vPDT group. Dependency scores increased by 3.7 points (P = 0.028) and 3.1 points (P = 0.027) in the stabilization and disease activity groups compared with a decrease of 4.7 points in the vPDT group. At month 12, increases appeared to be maintained from month 3 for the composite (6.6, 5.1), near activities (12.1, 5.6), mental health (9.0, 8.9) and dependency (6.3, 4.0) scores for stabilization and disease activity groups, respectively.
Average improvement in patient-reported visual functioning among individuals with CNV secondary to pathologic myopia appears greater for the NEI VFQ-25 composite score, near activities, mental health and dependency subscales at 3 months with ranibizumab compared with vPDT. Improvements in the ranibizumab groups were sustained or further improved through 12 months and provide evidence of patient-reported benefit with ranibizumab when treating patients with CNV secondary to pathologic myopia who have characteristics similar to those enrolled in this trial.