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

EyePoint Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Nonproliferative Diabetic Retinopathy

Treatments: Drug: EYP-1901; Other: Sham IVT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05383209

EYP-1901-204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 3 patient groups

EYP-1901 2060 ug

Experimental group

Description:

EYP-1901 2060 ug; single injection

Treatment:

Drug: EYP-1901

EYP-1901 3090 ug

Experimental group

Description:

EYP-1901 3090 ug; single injection

Treatment:

Drug: EYP-1901

Sham IVT

Sham Comparator group

Description:

Sham IVT; single injection

Treatment:

Other: Sham IVT