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

Nonproliferative Diabetic Retinopathy Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383209
• Other study ID #: EYP-1901-204
• Status: Recruiting
• Phase: Phase 2
• Start date: August 31, 2022
• Est. completion date: August 2025

Study information

• Verified date: February 2023
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: Dario Paggiarino, MD
• Phone: 8589670016
• Email: dpaggiarino[@]eyepointpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Nonproliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• EYP-1901
Intravitreal Injection

Other:
• Sham IVT
Sham IVT

Locations

Country	Name	City	State
United States	EyePoint Investigative Site	Austin	Texas
United States	EyePoint Investigative Site	Bellevue	Washington
United States	EyePoint Investigative Site	Clearwater	Florida
United States	EyePoint Investigative Site	Florence	South Carolina
United States	EyePoint Investigative Site	Germantown	Tennessee
United States	EyePoint Investigative Site	Houston	Texas
United States	EyePoint Investigative Site	Huntington Beach	California
United States	EyePoint Investigative Site	Indianapolis	Indiana
United States	EyePoint Investigative Site	Ladson	South Carolina
United States	EyePoint Investigative Site	Lemont	Illinois
United States	EyePoint Investigative Site	Lenexa	Kansas
United States	EyePoint Investigative Site	McAllen	Texas
United States	EyePoint Investigative Site	Melbourne	Florida
United States	EyePoint Investigative Site	Miami	Florida
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	Phoenix	Arizona
United States	EyePoint Investigative Site	Plano	Texas
United States	EyePoint Investigative Site	Reno	Nevada
United States	EyePoint Investigative Site	Sacramento	California
United States	EyePoint Investigative Site	San Antonio	Texas
United States	EyePoint Investigative Site	Springfield	Massachusetts
United States	EyePoint Investigative Site	The Woodlands	Texas
United States	EyePoint Investigative Site	Toms River	New Jersey
United States	EyePoint Investigative Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline, Week 36
Secondary	Percentage of subjects improving =2 steps in the DRSS score in each dose level vs. sham		Baseline, Week 24, Week 48
Secondary	Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy		Week 24, Week 36, Week 48
Secondary	Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events		Week 24, Week 36, Week 48