Improved vision-related function after ranibizumab vs photodynamic therapy: A randomized clinical trial

Objective: To compare patient-reported visual function in those with neovascular age-related macular degeneration treated with ranibizumab or verteporfin photodynamic therapy (PDT). Design: Multicenter, double-masked, phase 3 trial (ANCHOR). Participants were randomized in a 1:1:1 ratio to receive 0.3 or 0.5mgof intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered at baseline and 1, 2, 3, 6, 9, 12, 18, and 24 months. Main Outcome Measure: Mean change from baseline in NEI VFQ-25 scores at 12 months. Results: At 12 months, patients treated with ranibizumab (0.3 mg [n=137] or 0.5 mg [n=139]) had mean improvements in NEI VFQ-25 composite scores of 5.9 (95% confidence interval [CI], 3.6 to 8.3) and 8.1 (95% CI, 5.3 to 10.8) points, respectively; patients treated with PDT(n=142) had a mean improvement of 2.2 points (95% CI, -0.3 to 4.7; vs 0.5 mg of ranibizumab, P<.001; vs 0.3 mg of ranibizumab, P=.003). At each dose through 24 months, patients treated with ranibizumab were more likely to improve in most subscales, including the pre-specified subscales (near activities, distance activities, and vision-specific dependency). Conclusions: Patients treated with ranibizumab were more likely to report clinically meaningful improvements in visual function through 24 months compared with those treated with verteporfin PDT. Application to Clinical Practice: Ranibizumab treatment in neovascular age-related macular degeneration can improve patient-reported visual function. Trial Registration: clinicaltrials.gov Identifier: NCT00061594.