Efficacy & safety of 2 different aflibercept regimens in nAMD subjects

• Research type

  Research Study

• Full title

  An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of 2 mg aflibercept administered by intravitreal injections using two different treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

• IRAS ID

  183395

• Contact name

  James Talks

• Contact email

  James.Talks@nuth.nhs.uk

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2013-000120-33

• Duration of Study in the UK

  2 years, 8 months, 1 days

• Research summary

  This study is designed to find out more about the effectiveness of two different therapy regimens for Aflibercept after the first year of treatment in participants suffering from neovascular age-related macular degeneration (nAMD).

  Aflibercept is a licensed drug for the treatment of this condition and approved by NICE. It is an effective treatment for improving and preserving central vision in patients with neovascular age-related macular degeneration (nAMD).

  In the first year the recommended treatment regime is 3 injections 4 weeks apart then 8 weekly for a year. The issue is, what is the best treatment regime in the second year that minimises the burden on the patient and the health care system? In the second year of the licensing studies (VIEW1 and 2) participants were brought back every month, as this study was comparing aflibercept to ranibizumab. Treatment was mandated every 3 months and could be given at intervening visits if need be. This study aims to see if continuing an 8 weekly regime in the second year or potentially extending treatment intervals, depending on certain findings, continues to maintain the vision benefit obtained in the first year.
  The study will be conducted at hospital sites ; male and female participants are eligible aged 51 or over. The study comprises a screening period of up to 8 weeks and a treatment period of 72 weeks. It is expected participants will receive treatment for up to 72 weeks or up to 76 weeks in the extended dosing group with a final study visit at week 76.

  During the study participants will be required to give blood and urine samples, have vision tests, retinal photography and be asked to complete questionnaires.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  15/NE/0278

• Date of REC Opinion

  28 Sep 2015

• REC opinion

  Further Information Favourable Opinion