Efficacy and Safety of RTH258 versus Aflibercept

• Research type

  Research Study

• Full title

  A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RTH258 6 mg Versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration

• IRAS ID

  178877

• Contact name

  Robin Hamilton

• Contact email

  Robin.Hamilton@moorfields.nhs.uk

• Sponsor organisation

  Alcon Research Ltd

• Eudract number

  2014-004886-26

• Clinicaltrials.gov Identifier

  NCT02307682

• Duration of Study in the UK

  2 years, 11 months, 19 days

• Research summary

  AMD (Age Related Macular Degeneration) is the leading cause of severe sight loss and blind registration in the UK. Patients can have difficulties with every day tasks such as recognising faces, reading & driving.
  
  There are two variations of the disease, a 'dry' type and a 'wet' type also known as neovascular AMD (nAMD). In nAMD new vessels grow from underneath the retina (back of the eye) into the macula (the area at the back of the eye responsible for sharpness of eyesight), these vessels may leak or bleed and cause severe loss of eyesight. Growth of abnormal vessels involves a protein called Vascular Endothelial Growth Factor (VEGF). Drugs which block VEGF (Anti-VEGF) can help to prevent eye sight from worsening and even improve eye sight in patients diagnosed with nAMD.
  
  In this study patients may receive treatment with a licensed anti-VEGF, Aflibercept (Eylea®) 2mg or a new anti-VEGF called RTH258 6mg. At first, treatment will be given every 4 weeks for the first 3 months (loading phase) and then every 12 weeks for those receiving RTH258 and 8 weekly for those receiving Aflibercept (Eylea®). There will be opportunity for those receiving RTH258 to have their treatment interval reduced to 8 weekly if deemed necessary by the doctor, at various time points during the course of the study.

  The purpose for the study is to determine if RTH258 is equally as effective as Aflibercept (Eylea®) in the treatment of nAMD, as assessed by change in eyesight at week 48 of the study. 660 patients will be treated at 200 centres globally, the UK will contribute 60 patients from 15 sites.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  15/LO/1166

• Date of REC Opinion

  8 Sep 2015

• REC opinion

  Further Information Favourable Opinion