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

NCT05383209 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EYP-1901-204
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 36

Brief 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

Keywords

NPDR; EYP-1901; EyePoint

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36

  The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.

  Baseline (Day 1) and Week 36

Secondary Outcomes (12)

• Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48

  Baseline (Day 1), Week 24, and Week 48

• Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48

  Baseline (Day 1) and Weeks 24, 36 and 48

• Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48

  Baseline (Day 1) and Weeks 24, 36 and 48

• Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48

  Weeks 24, 36 and 48

• Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48

  Weeks 24, 36 and 48

Study Arms (3)

EYP-1901 2060 ug

EXPERIMENTAL

EYP-1901 2060 ug; single injection

Drug: EYP-1901

EYP-1901 3090 ug

EXPERIMENTAL

EYP-1901 3090 ug; single injection

Drug: EYP-1901

Sham IVT

SHAM COMPARATOR

Sham IVT; single injection

Other: Sham IVT

Interventions

EYP-1901 DRUG

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.

Also known as: Vorolanib

EYP-1901 2060 ug; EYP-1901 3090 ug

Sham IVT OTHER

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

Sham IVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (36)

EyePoint Investigative Site

Phoenix, Arizona, 85020, United States

Location

EyePoint Investigative Site

Huntington Beach, California, 92647, United States

Location

EyePoint Investigative Site

Oxnard, California, 93036, United States

Location

EyePoint Investigative Site

Palm Desert, California, 92211, United States

Location

EyePoint Investigative Site

Pasadena, California, 90041, United States

Location

EyePoint Investigative Site

Poway, California, 92064, United States

Location

EyePoint Investigative Site

Sacramento, California, 95825, United States

Location

EyePoint Investigative Site

Danbury, Connecticut, 06810, United States

Location

EyePoint Investigative Site

Clearwater, Florida, 33761, United States

Location

EyePoint Investigative Site

Melbourne, Florida, 32901, United States

Location

EyePoint Investigative Site

Miami, Florida, 33143, United States

Location

EyePoint Investigative Site

Winter Haven, Florida, 33880, United States

Location

EyePoint Investigative Site

Lemont, Illinois, 60439, United States

Location

EyePoint Investigative Site

Indianapolis, Indiana, 46290, United States

Location

EyePoint Investigative Site

Lenexa, Kansas, 66215, United States

Location

EyePoint Investigative Site

Baltimore, Maryland, 21209, United States

Location

EyePoint Investigative Site

Hagerstown, Maryland, 21740, United States

Location

EyePoint Investigative Site

Springfield, Massachusetts, 01107, United States

Location

EyePoint Investigative Site

Reno, Nevada, 89502, United States

Location

EyePoint Investigative Site

Bloomfield, New Jersey, 07003, United States

Location

EyePoint Investigative Site

Toms River, New Jersey, 08755, United States

Location

EyePoint Investigative Site

Great Neck, New York, 11021, United States

Location

EyePoint Investigative Site

Erie, Pennsylvania, 16501, United States

Location

EyePoint Investigative Site

Florence, South Carolina, 29501, United States

Location

EyePoint Investigative Site

Ladson, South Carolina, 29456, United States

Location

EyePoint Investigative Site

Rapid City, South Dakota, 57701, United States

Location

EyePoint Investigative Site

Germantown, Tennessee, 38138, United States

Location

EyePoint Investigative Site

Abilene, Texas, 79606, United States

Location

EyePoint Investigative Site

Austin, Texas, 78705, United States

Location

EyePoint Investigative Site

Houston, Texas, 78240, United States

Location

EyePoint Investigative Site

McAllen, Texas, 78503, United States

Location

EyePoint Investigative Site

Plano, Texas, 75075, United States

Location

EyePoint Investigative Site

San Antonio, Texas, 78247, United States

Location

EyePoint Investigative Site

The Woodlands, Texas, 77384, United States

Location

EyePoint Investigative Site

Lynchburg, Virginia, 24502, United States

Location

EyePoint Investigative Site

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Interventions

vorolanib

Results Point of Contact

• Title: Ramiro Ribeiro, MD, PhD
• Organization: EyePoint Pharmaceuticals, Inc.

rribeiro@eyepointpharma.com

908-440-0979

Study Officials

• Ramiro Ribeiro, MD, PhD

  EyePoint Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 20, 2022
• Study Start: September 28, 2022
• Primary Completion: February 12, 2024
• Study Completion: May 6, 2024
• Last Updated: August 15, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)