PHOTON

• Research type

  Research Study

• Full title

  A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients with Diabetic Macular Edema

• IRAS ID

  275644

• Contact name

  Catherine Carter

• Contact email

  Catherine.Carter@Parexel.com

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2019-003643-30

• Clinicaltrials.gov Identifier

  NCT04429503

• Clinicaltrials.gov Identifier

  US IND Number, 12462

• Duration of Study in the UK

  2 years, 6 months, 1 days

• Research summary

  High-dose aflibercept (HD) is being studied for treatment of diabetic macular edema (DME) in this study.
  Aflibercept is a protein that binds to vascular endothelial growth factor-A (VEGF-A). VEGF-A is a protein involved in the abnormal growth of new blood vessels in the eye in certain diseases such as DME. By blocking the effects of these proteins, aflibercept has been shown to decrease the abnormal growth and leakage of the new blood vessels that can lead to vision problems.

  The study drug is given as an injection in the eye. High-dose aflibercept is being studied to investigate whether an 8 mg dose of aflibercept can result in a longer time between injections without compromising potential gains in vision compared to current treatment with 2 mg aflibercept.
  After the screening visit, eligible participants will be enrolled at a 1:2:1 chance, of receiving:
  • IAI (Intravitreal Aflibercept Injection 2 mg) given every 4 weeks for 5 initial doses and then every 9 weeks to end of study (160 participants)
  • HD (aflibercept 8 mg) given every 4 weeks for 3 initial doses and then every 12 weeks to end of study (320 participants)
  • HD (aflibercept 8 mg) given every 4 weeks for 3 initial doses and then every 12 weeks to end of study (160 participants)
  This is a randomised, double-masked study. “Randomised” means the group participants will be placed in is decided by chance, similar to flipping a coin. “Double-masked” means neither the participant nor the study doctor will know who is receiving 2 mg aflibercept or high-dose aflibercept.
  This study is sponsored by Regeneron Pharmaceuticals, Inc. and will include about 640 participants at about 180 research sites in North America, Europe and Asia.
  Lay summary of study results: When available, a plain language summary of results will be posted on TrialSummaries.com:
  https://clinicaltrials.gov/study/NCT04429503?tab=results

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  20/SC/0110

• Date of REC Opinion

  3 Jun 2020

• REC opinion

  Further Information Favourable Opinion