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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

RecruitingPhase 3

Sponsor: EyePoint Pharmaceuticals, Inc.

Conditions: Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)

Interventions: EYP-1901, Aflibercept (2.0 mg)

Countries: United States, Germany, Israel, Poland, Slovakia

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.

Exclusion Criteria:

* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.

Locations (73)

Bakersfield, California, United States
Encino, California, United States
Glendale, California, United States
Mountain View, California, United States
Poway, California, United States
Redlands, California, United States
Sacramento, California, United States
Sacramento, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Boynton Beach, Florida, United States
Deerfield Beach, Florida, United States
Pinellas Park, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Wesley Chapel, Florida, United States
Marietta, Georgia, United States
‘Aiea, Hawaii, United States
Plainfield, Illinois, United States
Carmel, Indiana, United States
West Monroe, Louisiana, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Hagerstown, Maryland, United States
Towson, Maryland, United States
Springfield, Massachusetts, United States
Grand Blanc, Michigan, United States
Grand Rapids, Michigan, United States
Reno, Nevada, United States
Teaneck, New Jersey, United States
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