Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (VERONA)

EyePoint Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; Drug: EYP-1901

Study type: Interventional

Funder types: Industry

Identifiers

NCT06099184

EYP-1901-202

Details and patient eligibility

About

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

Full description

A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
• Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
• BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion criteria

• Any current or history of ocular disease other than DME
• BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
• Active ocular inflammation or active infection in either eye at Baseline (Day 1).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 3 patient groups

EYP-1901 1343 µg

Experimental group

Description:

EYP-1901 1343 µg, single dose

Treatment:

Drug: EYP-1901

EYP-1901 2686 µg

Experimental group

Description:

EYP-1901 2686 µg, single dose

Treatment:

Drug: EYP-1901

Aflibercept

Active Comparator group

Description:

Aflibercept 2 mg/0.05mL solution, single dose

Treatment:

Drug: Aflibercept 2Mg/0.05Ml Inj,Oph