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