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Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

NCT05383209•EyePoint Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This study evaluated the ocular efficacy and safety of two doses of the EYP-1901 IVT insert compared to sham using a randomized double-masked trial design.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).

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

Locations (36)

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

Key Dates

Start Date

September 28, 2022

Primary Completion Date

February 12, 2024

Completion Date

May 6, 2024

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

Nonproliferative Diabetic Retinopathy

Interventions

EYP-1901

DRUG

Sham IVT

OTHER

The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)

NCT03197870

Nonproliferative Diabetic Retinopathy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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