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

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonproliferative Diabetic Retinopathy

In brief

A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.

Key facts

Study ID

NCT05383209

Run by

EyePoint Pharmaceuticals, Inc.

People needed

77

Starts

2022-09-28

Expected to finish

2024-05-06

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have a hemoglobin A1c <=12%
• Study eye with moderately severe to severe Non proliferative Diabetic Retinopathy (NPDR) (based on the Diabetic Retinopathy Severity Scale (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).

You may not qualify if…

• 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 (PRP) in the study eye in the last 12 months.

Where it is running

• EyePoint Investigative Site — Phoenix, Arizona, United States
• EyePoint Investigative Site — Huntington Beach, California, United States
• EyePoint Investigative Site — Oxnard, California, United States
• EyePoint Investigative Site — Palm Desert, California, United States
• EyePoint Investigative Site — Pasadena, California, United States
• EyePoint Investigative Site — Poway, California, United States
• EyePoint Investigative Site — Sacramento, California, United States
• EyePoint Investigative Site — Danbury, Connecticut, United States
• EyePoint Investigative Site — Clearwater, Florida, United States
• EyePoint Investigative Site — Melbourne, Florida, United States
• EyePoint Investigative Site — Miami, Florida, United States
• EyePoint Investigative Site — Winter Haven, Florida, United States
• EyePoint Investigative Site — Lemont, Illinois, United States
• EyePoint Investigative Site — Indianapolis, Indiana, United States
• EyePoint Investigative Site — Lenexa, Kansas, United States
• EyePoint Investigative Site — Baltimore, Maryland, United States
• EyePoint Investigative Site — Hagerstown, Maryland, United States
• EyePoint Investigative Site — Springfield, Massachusetts, United States
• EyePoint Investigative Site — Reno, Nevada, United States
• EyePoint Investigative Site — Bloomfield, New Jersey, United States
• EyePoint Investigative Site — Toms River, New Jersey, United States
• EyePoint Investigative Site — Great Neck, New York, United States
• EyePoint Investigative Site — Erie, Pennsylvania, United States
• EyePoint Investigative Site — Florence, South Carolina, United States
• EyePoint Investigative Site — Ladson, South Carolina, United States

Full record on ClinicalTrials.gov

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