Clinical Studies:

VIEW 1 Extension

Summarized by Kyle Kovacs, MD (Weill Cornell Medicine Department of Ophthalmology)

Citation: Kaiser PK, Singer M, Tolentino M, Vitti R, Erickson K, Saroj N, Berliner AJ, Chu KW, Zhu X, Williams Liu Z, Clark WL. Long-term Safety and Visual Outcome of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: VIEW 1 Extension Study. Ophthalmol Retina. 2017 Jul-Aug;1(4):304-313.

Key Points

  • The VIEW 1 trial was a Phase III multicenter, double-masked, randomized, parallel group, active treatment-controlled trial in the United States assessing the safety and efficacy of aflibercept for exudative macular degeneration
  • Vision gains with aflibercept during the initial 52 weeks of the VIEW 1 study were largely maintained through a median 116 weeks extension, with no new safety profile concerns
  • Objective

    To assess the long-term safety and vision change in patients who received intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration in an extension study after completing VIEW 1 trial.

  • STUDY DESIGN

    Prospective , multicenter, open-label, randomized, extension study. After the initial 96 weeks of the VIEW 1 study, patients were enrolled in the extension study through week 212

  • DURATION

    212 weeks total, 116 week extension beyond the original 96 weeks of the VIEW 1 study

STUDY SUBJECTS

Major inclusion criteria:


Major exclusion criteria:


RANDOMIZATION SCHEME AND INTERVENTIONS

Patients were randomized in a 1:1:1:1 ratio into one of the following treatment groups for the first 52 weeks:

Then modified quarterly injections of the same regimen from weeks 52 to 96


Extension study patients (weeks 96 to 212) received 2mg aflibercept on a modified quarterly schedule followed by at least an every 8 week dosing


RESULTS

Study population


Primary Endpoint

Secondary Endpoints


CONCLUSIONS

Aflibercept 2mg dosing regimen in the extension study was largely able to maintain the vision gains of the original VIEW 1 study, with no new safety concerns identified.