Purpose:
To examine the effects of ranibizumab (Lucentis®) on self-reported perception of driving function in patients (pts) with neovascular AMD in ANCHOR, a phase III, randomized, controlled, double-masked trial.
Methods:
Pts were randomized 1:1:1 to PDT + sham intravitreal injection, ranibizumab 0.3 mg + sham PDT, or ranibizumab 0.5 mg + sham PDT. Ranibizumab (or sham) was given monthly; PDT (or sham) was given at day 0 then quarterly as needed. One eye per pt was treated. Driving status and self-reported perception of driving function were measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), although not defined a priori as key subscales to assess ranibizumab efficacy. Mean change from baseline in subscale scores at month 12 and 24 were compared between the PDT and 0.5 mg ranibizumab groups. NEI-VFQ-25 subscales are scored 0-100; a positive change represents improved function.
Results:
At baseline, 59.9% of PDT pts and 65.9% of 0.5 mg ranibizumab pts reported they were still driving. At month 12 and 24, respectively, 52.0% and 48.6% of PDT pts vs. 74.0% and 75.4% of 0.5 mg ranibizumab pts reported they were still driving. Changes in the driving subscale are shown below.ANCHOR: Change in Driving Function Subscale of the NEI VFQ-25 at 12 and 24 months*ranibizumab 0.5 mg vs. PDT, p<0.005
Conclusions:
At month 12 and 24, fewer PDT than ranibizumab pts reported they were still driving. Also, perception of driving function decreased more for PDT than ranibizumab pts over 24 months. These results suggest that ranibizumab patients reported better vision-related driving function.
Clinical Trial:
www.clinicaltrials.gov NCT00061594
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials