Impact of Ranibizumab on Patient-Reported Visual Functioning in Myopic Choroidal Neovascularization: 3- and 6-Month Results

Abstract

Purpose: To examine the effects of 0.5 mg ranibizumab given for 6 months on visual functioning among patients with myopic choroidal neovascularization (CNV).

Methods: In a phase 3, multi-country study, patients were randomized to: at least two monthly ranibizumab injections with subsequent retreatment based on visual acuity criteria (stabilization group, n = 106); at least one ranibizumab injection with subsequent retreatment based on optical coherent tomography or fluorescein angiography features (disease activity group, n = 116); or verteporfin photodynamic therapy (vPDT, n = 55). From month 3, patients assigned to vPDT could receive ranibizumab. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered in the local language at baseline, 3 months and 6 months to measure patient-reported visual functioning. Initial results from an exploratory analysis (including descriptive p-values) are reported using last observation carried forward analysis.

Results: 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. At month 3, the mean increase from baseline in NEI VFQ-25 composite score was greater in the stabilization (5.3 points, p < 0.05) and disease activity (4.3 points, p < 0.05) groups than in the vPDT group (0.3 points). At month 6, the mean increase from baseline in the composite score was 6.3 and 5.1 points in each ranibizumab group, respectively. In the subscales of near activities and mental health, some greater improvements were observed with ranibizumab (both groups) than with vPDT. At month 3, the mean increase from baseline in near activities score was 11.5 points (p < 0.01) 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 < 0.05) and 4.9 points (p < 0.05) and decreased by 1.8 points in these groups, respectively. At month 6, the increase from baseline was sustained at 10.0 and 6.5 points for near activities and 10.3 and 8.9 points for mental health in the stabilization and disease activity groups, respectively.

Conclusions: The improvement in patient-reported visual functioning in patients with myopic CNV was greater for some NEI VFQ-25 subscales at 3 months with ranibizumab than with vPDT. These improvements were sustained at 6 months.

Keywords: 453 choroid: neovascularization • 605 myopia • 754 visual acuity