20090 - Phase 3 - Aflibercept for ROP – IVT injection vs laser therapy

• Research type

  Research Study

• Full title

  Open-label, randomized, two–arm, controlled study to assess the efficacy, safety, and tolerability of intravitreal (IVT) aflibercept compared to laser photocoagulation in patients with retinopathy of prematurity (ROP).

• IRAS ID

  264648

• Contact name

  Jane Ashworth

• Contact email

  jane.ashworth@mft.nhs.uk

• Sponsor organisation

  Bayer AG

• Eudract number

  2018-002611-99

• Duration of Study in the UK

  1 years, 5 months, 7 days

• Research summary

  The purpose of this study is to confirm how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  19/NE/0195

• Date of REC Opinion

  13 Aug 2019

• REC opinion

  Further Information Favourable Opinion