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

NCT05383209 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-08-15

Study results available
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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.

Conditions

  • Nonproliferative Diabetic Retinopathy

Interventions

DRUG

EYP-1901

EYP-1901 will be administered to the study eye by a single injection through the pars plana using a pre-loaded applicator with a 22-gauge needle. Each EYP-1901 IVT insert has been designed to deliver vorolanib into the vitreous humor for approximately 6 to 9 months.

OTHER

Sham IVT

Sham injections will be used to maintain masking of investigational EYP-1901 therapy for study subjects.

Sponsors & Collaborators

  • EyePoint Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ramiro Ribeiro, MD, PhD · EyePoint Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2024-02-12
Completion
2024-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383209 on ClinicalTrials.gov