Aflibercept (4) – Eylea®

• Clinical trials
  • The VIBRANT trial was the registration trial for aflibercept in the indicated therapeutic indication.
  • A total of 91 patients were randomised to receive aflibercept and 92 patients to GRID laser therapy.

Patients with impaired visual acuity due to macular oedema resulting from a retinal vein branch occlusion (RVBO)

• For patients with impaired visual acuity due to macular oedema resulting from retinal vein branch occlusion, additional benefit is not proven.
• The study submitted by the pharmaceutical manufacturer is not suitable for assessing the additional benefit of aflibercept compared with the G-BA’s appropriate comparator therapy.
• This is because aflibercept was used in a manner deviating from the authorised treatment regimen and the G-BA’s appropriate comparator therapy was not implemented in the study.
• No study has been identified that directly compares aflibercept with ranibizumab.
• On the basis of the information in the dossier, the IQWiG’s benefit assessment and the comments on the benefit assessment, the G-BA concludes that the additional benefit of aflibercept over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.