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, Inc.
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Angie Adler
This study will assess the effectiveness and safety of high-dose aflibercept (HD) in patients with Diabetic Macular Edema (DME)
Patients will be randomly assigned to one out of three study treatment groups. The study will compare high-dose aflibercept at intervals of 12 or 16 weeks to to 2 mg aflibercept dosed every 8 weeks.
Diagnosis and Key Eligibility Criteria:
At least 18 years of age with type 1 or type 2 diabetes mellitus and a Snellen score of approximately 20/32 to 20/320 in the study eye with decreased vision determined to be primarily the result of DME. Patients cannot have had any previous treatment with any anti-VEGF therapy or vitreoretinal surgery in the study eye at any time prior to baseline. Patients may have had investigational therapy but require a washout period of 12 weeks in the study eye or 4 weeks in the fellow eye before screening.
Duration of study: Approximately 24 months
For more information, contact Angie Adler 608-265-7557