Purpose:
To assess the relationship between changes in visual acuity (VA) and the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in individuals treated for neovascular AMD. This analysis examines seemingly paradoxical results of treatment with ranibizumab (Lucentis®) on VA and visual function in ANCHOR, a Phase III randomized trial.
Methods:
Participants were randomized 1:1:1 to PDT, 0.3mg ranibizumab, and 0.5mg ranibizumab. VA was measured by ETDRS. VA change categories were based on mean change from baseline at 2 years: VA loss (<=5 letters lost), no change in VA (-4 letters to +4 letters), VA gain (>=5 letters gained). Visual function was assessed by the NEI VFQ-25, using the overall composite score. NEI VFQ-25 change categories were based on mean change from baseline at 2 years: NEI VFQ-25 loss (<= 5 points lost), NEI VFQ-25 no change (-4 points to +4 points), NEI VFQ-25 gain (>=5 points gained).
Results:
Seemingly paradoxical results were observed in both PDT and ranibizumab groups: 20.5% and 17.2% of patients had divergence between the direction of change in VA and visual function. Results will also be presented by better- and worse-seeing eye.
Conclusions:
These results suggest that visual acuity gains and losses are not always accompanied by similar patient-reported visual function results, confirming the importance of both measures in understanding the impact of AMD and its treatment on patients. Understanding the frequency and timing of seemingly paradoxical results may help distinguish differences between these two important measures of treatment effect.
Clinical Trial:
www.clinicaltrials.gov NCT00056836
Keywords: age-related macular degeneration • quality of life • clinical (human) or epidemiologic studies: outcomes/complications