NCT05383209

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: EyePoint Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Nonproliferative Diabetic Retinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-28
• Primary completion: 2024-02-12
• Completion: 2024-05-06
• First posted: 2022-05-20
• Last updated: 2025-08-15
• Results posted: 2025-07-28

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study