Intravitreal Aflibercept in patients with diabetic eye disease

• Research type

  Research Study

• Full title

  A Phase 3, Double-Masked, Randomised Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients with Moderately Severe to Severe Nonproliferative Diabetic Retinopathy

• IRAS ID

  215467

• Contact name

  Connie Sweeney

• Contact email

  connie.sweeney@parexel.com

• Sponsor organisation

  Regeneron Parmaceuticals, Inc

• Eudract number

  2016-002639-14

• Clinicaltrials.gov Identifier

  NCT02718326

• Duration of Study in the UK

  2 years, 10 months, 31 days

• Research summary

  Nonproliferative diabetic retinopathy (NPDR) is a diabetic eye disease. In early stages of the disease vision changes may not be noticed, but as the disease worsens, patients are at risk of events that can lead to vision loss and blindness.

  Currently there is no approved treatment that can treat or prevent NPDR from developing. The purpose of this research study is to see if Intravitreal Aflibercept Injection (or “aflibercept”) can improve NPDR and prevent this disease from worsening.

  About 360 participants will take part in the research study at research sites globally. After the screening visit, participants who are confirmed eligible to be enrolled in the study, will be randomly assigned to receive study drug (aflibercept 2 mg) or a fake (sham) injection in 1 of 3 treatment groups in a 1:1:1 ratio:
  • Aflibercept 2 mg every 8 weeks (2 months) to week 48 (after 5 initial monthly doses), followed by a flexible treatment regimen with aflibercept 2 mg to week 96.

  • Aflibercept 2 mg every 16 weeks (4 months) to week 96 (after 3 initial monthly doses and an additional dose in an eight week interval).
  • Sham: sham injections every 4 weeks (monthly) to week 16, followed by sham injections every 8 weeks (2 months) to week 96.

  This is a Phase 3, double-masked, randomised study, which means that neither the participants nor the study doctor will know which treatment group the patient is assigned to. At each treatment visit, study drug or sham injection will be administered, so that participants will not know what treatment group they are assigned to (to maintain the mask).

  This study is sponsored by Regeneron Pharmaceuticals, Inc.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  17/SC/0022

• Date of REC Opinion

  17 Mar 2017

• REC opinion

  Further Information Favourable Opinion