PHOTON

Actively Recruiting // Clinical Trials // Diabetic Macular Edema // Mihai Mititelu // Sep 28 2020

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 (PHOTON)

  • Sponsor: Regeneron Pharmaceuticals
  • Principal Investigator: Mihai Mititelu, MD, MPH
  • Study Coordinator: Angie Adler

Study objective:

To determine if treatment with high dose aflibercept provides non-inferior best corrected visual acuity compared to the standard dose aflibercept.

Study design:

Patients will receive treatment with high dose aflibercept (HD) at intervals of 12 or 16 weeks, or a standard dose of aflibercept every 8 weeks. Participation will last approximately 2 years.

Inclusion criteria:

  • Diabetic macular edema (DME) with central involvement in the study eye
  • Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME

Exclusion criteria:

  • Evidence of macular edema due to any cause other than diabetes mellitus in either eye
  • Active proliferative diabetic retinopathy in the study eye
  • IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
  • Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
  • Treatment with ocriplasmin (JETREA┬«) in the study eye at any time

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.gov