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

NCT07449923

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, Brazil, Czechia, Germany, Hungary

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 (70)
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Beverly Hills, California, United States
  • Fullerton, California, United States
  • Long Beach, California, United States
  • Modesto, California, United States
  • Oakland, California, United States
  • Redlands, California, United States
  • Walnut Creek, California, United States
  • Arvada, Colorado, United States
  • Danbury, Connecticut, United States
  • Greenwich, Connecticut, United States
  • Waterford, Connecticut, United States
  • Fort Lauderdale, Florida, United States
  • Pensacola, Florida, United States
  • Plantation, Florida, United States
  • South Miami, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Elmhurst, Illinois, United States
  • Lemont, Illinois, United States
  • Oak Park, Illinois, United States
  • Carmel, Indiana, United States
  • Louisville, Kentucky, United States
  • Metairie, Louisiana, United States
  • Hagerstown, Maryland, United States
  • Hagerstown, Maryland, United States
  • Worcester, Massachusetts, United States
  • + 40 more on CT.gov