Clinical Studies:


Summarized by Michael Ryan, MD (Weill Cornell Medicine Department of Ophthalmology)

Citation: Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48.

Key Points

  • The VIEW 1 trial was a Phase III multicenter, double-masked, randomized, parallel group, active treatment-controlled trial in the United States, and VIEW 2 trial was a similarly designed study in Europe, Asia, and Latin America, assessing the safety and efficacy of aflibercept for exudative macular degeneration
  • Aflibercept dosed monthly or every two months after initial loading regimen was noninferior to monthly ranibizumab with regards to vision and anatomic outcomes
  • Objective

    To determine the safety and efficacy of various doses and regimens of intravitreal aflibercept as compared to intravitreal ranibizumab for the treatment of nAMD.


    Phase 3, multicenter, double-masked, randomized, parallel group, active treatment-controlled trials


    52 weeks

Two primary endpoints for the studies:

Of note, the statistical analysis for each study prospectively accounted for an integrated analysis of the data from VIEW 1 and VIEW 2.

Primary endpoints were calculated using both intention-to-treat and per-protocol analyses.


Major inclusion criteria:

Major exclusion criteria:


Patients were randomized in a 1:1:1:1 ratio into one of the following treatment groups:


Study population

Primary Endpoint

In the integrated analysis, all aflibercept regimens met the prespecified margins for noninferiority and clinical equivalence using both the intention-to-treat and per-protocol analyses. Using the per-protocol analysis, the proportion of patients maintaining vision for each of the treatment groups was:

Secondary Endpoints

Mean change in BCVA was investigated as a secondary endpoint. In the integrated analysis, all aflibercept regimens were found to be within 0.5 ETDRS letters of the ranibizumab regimen and there were no statistically significant differences among the treatment regimens.

Similarly, all anatomical endpoints and adverse events were comparable between all study regimens.