Vision-Related Function After Ranibizumab Treatment by Better- or Worse-Seeing Eye: 24 Month Results From MARINA

Abstract

 

Purpose:

 

To examine the impact of treatment with ranibizumab (Lucentis^TM)on patient-reported vision-related function (VRF) using theNEI VFQ-25 thru 24 months in a Phase III randomized clinicaltrial (MARINA), with reference to whether the study eye wasthe better- or worse-seeing eye at baseline.

 

Methods:

 

The NEI-VFQ 25 was administered to subjects with neovascularage-related macular degeneration (AMD) at baseline, months 1,2, 3, 6, 9, 12, 18, and 24. A 1:1:1 randomization was carriedout (sham, 0.3mg and 0.5mg). Results were compared between ranibizumab(0.5 mg dose) and sham at 24 months. VRF was assessed by changein mean score from baseline at month 24 for three prespecifiedsubscales (near activities, distance activities, vision-relateddependency). A positive difference represents improved functioning.

 

Results:

 

Mean changes at 24 months from baseline score were as follows: 

 

 

Conclusions:

 

In MARINA, at 24 months vision-related function improved relativeto sham following ranibizumab treatment whether the study eyewas the better- or worse-seeing eye at baseline, although greaterimprovement relative to sham was seen when the study eye wasthe better eye at baseline. These results suggest that the visualacuity improvements reported for MARINA can be associated withimprovements in vision-related function regardless of whetherthe better- or worse-seeing eye is treated.

 

Clinical Trial:

 

www.clinicaltrials.gov NCT00056836

 

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • quality of life