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

Primary Purpose

Nonproliferative Diabetic Retinopathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EYP-1901
Sham IVT
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonproliferative Diabetic Retinopathy focused on measuring NPDR, EYP-1901, EyePoint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting
  • EyePoint Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

EYP-1901 2060 ug

EYP-1901 3090 ug

Sham IVT

Arm Description

EYP-1901 2060 ug; single injection

EYP-1901 3090 ug; single injection

Sham IVT; single injection

Outcomes

Primary Outcome Measures

Percentage of subjects improving ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score each EYP-1901 dose level versus the sham IVT injection group.

Secondary Outcome Measures

Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham
Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy
Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events

Full Information

First Posted
May 10, 2022
Last Updated
February 13, 2023
Sponsor
EyePoint Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05383209
Brief Title
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyePoint Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonproliferative Diabetic Retinopathy
Keywords
NPDR, EYP-1901, EyePoint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EYP-1901 2060 ug
Arm Type
Experimental
Arm Description
EYP-1901 2060 ug; single injection
Arm Title
EYP-1901 3090 ug
Arm Type
Experimental
Arm Description
EYP-1901 3090 ug; single injection
Arm Title
Sham IVT
Arm Type
Sham Comparator
Arm Description
Sham IVT; single injection
Intervention Type
Drug
Intervention Name(s)
EYP-1901
Intervention Description
Intravitreal Injection
Intervention Type
Other
Intervention Name(s)
Sham IVT
Intervention Description
Sham IVT
Primary Outcome Measure Information:
Title
Percentage of subjects improving ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score each EYP-1901 dose level versus the sham IVT injection group.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham
Time Frame
Baseline, Week 48, Week 96
Title
Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy
Time Frame
Week 24, Week 48, Week 96
Title
Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events
Time Frame
Week 24, Week 48, Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dario Paggiarino, MD
Phone
8589670016
Email
dpaggiarino@eyepointpharma.com
Facility Information:
Facility Name
EyePoint Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Florence
State/Province
South Carolina
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78247
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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