Table 3.

QoL assessment in clinical trials of antivascular endothelial growth factor therapy for wAMD

Study	Treatment	QoL endpoints	Outcome*
VISION.26 A prospective, randomized, double-blind, multicenter, dose-ranging study	Pegaptanib (0.3 mg, 1 mg, and 3 mg) versus standard of care	NEI VFQ-25: near and distance vision, role limitations, and dependency score changes from baseline to endpoint	At week 54, distance vision and role limitations domains were significantly improved in pegaptanib versus usual care, with LS differences of 4–6 points overall, and 6–8 points for 3 mg dose.
MARINA.14 A randomized, double-masked, dose-ranging study	Ranibizumab (0.3 mg or 0.5 mg) versus sham	NEI VFQ-25 overall composite score and subscale score changes from baseline to endpoint	At 12 months, significant improvement in composite scores of 5–6 points was noted with both doses compared to a decline of 3 points with sham. Significant improvement of >4 points was observed for six of 12 subscales at the 0.5 mg dose. At 24 months, the largest improvements (.8 points) were seen in the subscales near activities, general vision, and mental health.
ANCHOR.13 A randomized, multicenter, double-masked, dose-ranging study	Ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin versus sham injections plus active verteporfin	NEI VFQ-25 overall composite score and subscale score changes from baseline to endpoint	At 12 months, improvement in composite scores was noted with both 0.3 mg and 0.5 mg doses (5.9 and 8.1 points, respectively), which was significantly greater compared to verteporfin photodynamic therapy (P < 0.01 and P < 0.001). At 24 months, greater improvement was observed in ranibizumab-treated patients on most subscales, including near and distance activities and dependency.
MARINA and ANCHOR.21 Multicenter, double-masked, control studies	Ranibizumab (0.3 or 0.5 mg) versus sham Data were analyzed separately for MARINA and ANCHOR and treatment groups were pooled within each trial	Regression models were used to assess change from baseline to 12 months in NEI VFQ-25 composite and subscale scores. Changes in VA at 12 months (>15 letters gained, <15 letters lost, >15 letters gained or lost)	Over 12 months, subgroups categorized by visual acuity change differed in mean change in NEI VFQ-25 composite, near and distance activities, and dependency scores. Results suggest that a 4–6 point improvement or more in NEI VFQ-25 scores (composite or subscale) represents a clinically meaningful change in visual acuity.
VIEW 1 and 2.25 Multicenter, double-masked, control studies	Intravitreal aflibercept (0.5 mg q4w; 2 mg q4w; 2 mg q8w after 3 loading doses q4w) versus ranibizumab 0.5 mg q4w. Data were integrated from two highly similarly designed trials	Regression models were used to assess change from baseline to 12 months in NEI VFQ-25 composite and subscale scores. Intravitreal aflibercept outcomes were compared to ranibizumab outcomes	Over 12 months, all treatment arms demonstrated improvement in the NEI VFQ-25 composite score, and near and distance activities subscale scores (range: 4.8 to 8.6 point change).

Notes:

^*Improvement of four points or more in NEI VFQ-25 scores represents a clinically meaningful change in visual acuity.²¹

Abbreviations: QoL, quality of life; wAMD, wet age-related macular degeneration; VISION, Vascular endothelial growth factor Inhibition Study In Ocular Neovascularization; NEI VFQ-25, National Eye Institute Visual Functioning Questionnaire 25-items; LS, least squares; MARINA, Minimally classic/occult trial of the Antivascular endothelial growth factor antibody Ranibizumab In the treatment of Neovascular Age-related macular degeneration; ANCHOR, Antivascular endothelial growth factor antibody for the treatment of predominantly classic CHoroidal Neovascularization in age-related macular degeneration; VIEW, vascular endothelial growth factor trap-eye; Investigation of Efficacy and safety in Wet age-related macular degeneration; q4w, every 4 weeks; q8w, every 8 weeks; VA, visual acuity.