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

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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 240

Sponsor: EyePoint Pharmaceuticals, Inc.

Location: Associated Retina Consultans Gilbert Arizona

Summary

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

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07449923). StuddyBuddy aggregates publicly available trial information.