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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2024-05-06

Brief Summary

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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.

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Detailed Description

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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

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Nonproliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EYP-1901 2060 ug

EYP-1901 2060 ug; single injection

Group Type EXPERIMENTAL

EYP-1901

Intervention Type 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.

EYP-1901 3090 ug

EYP-1901 3090 ug; single injection

Group Type EXPERIMENTAL

EYP-1901

Intervention Type 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.

Sham IVT

Sham IVT; single injection

Group Type SHAM_COMPARATOR

Sham IVT

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Sham IVT

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

Intervention Type OTHER

Other Intervention Names

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Vorolanib

Eligibility Criteria

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Inclusion Criteria

* 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).

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 (PRP) in the study eye in the last 12 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No