Overview

Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Status:
Not yet recruiting

Trial end date:
2025-08-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

EyePoint Pharmaceuticals, Inc.

Treatments:

Aflibercept

Criteria

Inclusion Criteria:

- Participants must have a hemoglobin A1c ≤12%

- Study eye with moderately severe to severe NPDR (based on the DRSS levels 47 or 53)

- Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study
(ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent
of 20/40 or better).

Exclusion Criteria:

- Presence of any active Center involved-diabetic macular edema in the study eye as
determined by the Investigator on clinical examination, or within the central subfield
thickness (CST) of the study eye, with a CST threshold greater than 320 microns.

- Any evidence or documented history of prior focal or grid laser photocoagulation or
any pan-retinal photocoagulation in the study eye in the last 12 months.