Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)

• Status: Not yet recruiting
• Trial end date: 2025-01-15
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EyePoint Pharmaceuticals, Inc.
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit

• Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.

• BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion Criteria:

• Any current or history of ocular disease other than DME

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

• Active ocular inflammation or active infection in either eye at Baseline (Day 1).