Subgroup Efficacy Analyses of the VIEW 1 and VIEW 2 Studies of Intravitreal Aflibercept Injection and Ranibizumab for Treatment of Neovascular AMD

Abstract

 

Purpose:

 

To determine the consistency of efficacy of intravitreal aflibercept injection (IAI; also referred to as VEGF Trap-Eye) across patient subgroups and ranibizumab (RBZ) for 1 year.

 

Methods:

 

A total of 2457 patients were randomized to RBZ 0.5 mg every month (Rq4wk), IAI 2 mg every month (2q4wk), 0.5 mg every month (0.5q4wk), or 2 mg every 2 months (2q8wk) following 3 initial monthly doses. In this subanalysis, proportions of patients losing <15 letters (proportion maintaining visual acuity) and mean change in best-corrected visual acuity (BCVA) at Week 52 were compared across subgroups based on patients' age, baseline visual acuity (VA) and baseline choroidal neovascularization (CNV) lesion size. The Breslow-Day test was used to assess homogeneity.

 

Results:

 

At baseline, all treatment subgroups were balanced with respect to age, BCVA, and CNV lesion size. At Week 52 across all subgroups, 93% to 100% of patients lost <15 letters on the ETDRS chart and the mean change in BCVA ranged from 6 to 16 letters. At Week 52, all IAI subgroups showed consistent proportions compared with RBZ (Table).

 

Conclusions:

 

Proportion of patients losing <15 letters and the mean changes in BCVA were consistent across the pre-specified subgroups as defined by age, baseline BCVA and CNV lesion size. Further, VA improved for all intravitreal aflibercept injection subgroups, including the 2q8wk group, and was similar to monthly ranibizumab.  

 

Clinical Trial:

 

http://www.clinicaltrials.gov NCT00509795

 

Keywords: neovascularization • vascular endothelial growth factor • visual acuity