A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
EyePoint Pharmaceuticals, Inc.
Summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit. * Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1). * For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the…
Interventions
- DrugEYP-1901
Intravitreal Injection
- DrugAflibercept (2.0 mg)
Intravitreal Injection
Locations (48)
- Associated Retina ConsultansGilbert, Arizona
- Associated Retina Consultants - PhoenixPhoenix, Arizona
- Phoenix Retina Clinical Trials, LLC - North PhoenixPhoenix, Arizona
- Retina Macula Institute of ArizonaScottsdale, Arizona
- Retina Vitreous Associates Medical GroupBeverly Hills, California
- Retina Consultants of Orange CountyFullerton, California