Cumulative Incidence of Visual Acuity Change in the VIEW 1 and VIEW 2 Studies of Patients with Neovascular Age-related Macular Degeneration

Abstract

 

Purpose:

 

To test the hypothesis that the time to sustained visual acuity gain or loss in wet AMD patients is similar among different dosing regimens of intravitreal aflibercept injection (IAI; also referred to as VEGF Trap-Eye), including every-two-month dosing, and monthly ranibizumab.

 

Methods:

 

A total of 2457 patients with AMD from VIEW 1 and VIEW 2 were randomized to four treatment groups: ranibizumab 0.5 mg every 4 weeks (Rq4wk), IAI 2 mg every 4 weeks (2q4wk), 0.5 mg every 4 weeks (0.5q4wk), and 2 mg every 8 weeks (2q8wk, after 3 initial monthly doses). In this study, the pre-specified analysis assessed the temporal pattern of the cumulative incidence of the following events: first gain or loss of ≥15 letters (simple event) and first ≥2 consecutive occurrences gain or loss of ≥15 letters (sustained event). Kaplan-Meier methodology was used to compare the cumulative incidence curves for the treatment groups. The analysis was adjusted for varying patterns of censorship.

 

Results:

 

Outcomes for ≥15 letters at Week 52 are shown in the table.Cumulative incidence curves did not differ among the four dosing regimens for the two anti-VEGF agents: P=0.69, P=0.75, P=0.92 and P=0.92 for the respective outcomes listed in the first column of the table. Improvement in vision was observed early in all treatment groups.

 

Conclusions:

 

Temporal patterns in visual acuity gain or loss were similar among all treatment groups, indicating that the every-two-months treatment with intravitreal aflibercept injection was as beneficial as monthly doses of intravitreal aflibercept injection or ranibizumab.  

 

Clinical Trial:

 

http://www.clinicaltrials.gov NCT00509795

 

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • vascular endothelial growth factor