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

Phase 2

Completed

• Conditions: Nonproliferative Diabetic Retinopathy
• Interventions: Drug: EYP-1901; Other: Sham IVT

• Registration Number: NCT05383209
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Study Start: 2022-08-31
• Status Verified: 2023-02
• Primary Completion: 2024-02-12
• Study Completion: 2024-05-06
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EYP-1901 2060 ug	EYP-1901	EYP-1901 2060 ug; single injection
EYP-1901 3090 ug	EYP-1901	EYP-1901 3090 ug; single injection
Sham IVT	Sham IVT	Sham IVT; single injection

Primary Outcome Measures

Name	Time	Method
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	Improvement in DRSS

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham	Baseline, Week 24, Week 48	Improvement in DRSS in dose levels and sham
Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy	Week 24, Week 36, Week 48	Percent of vision threatening complications due to DR
Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events	Week 24, Week 36, Week 48	Rates of AEs

Trial Locations

Locations (1)

EyePoint Investigative Site; 🇺🇸 Bellevue, Washington, United States