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Completed

NCT Number: NCT06099184

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

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

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

EyePoint Investigative Site, Phoenix, Arizona, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

EYP-1901

Drug

Intravitreal Injection

Other names: Vorolanib

Aflibercept 2Mg/0.05Ml Inj,Oph

Drug

Intravitreal Injection

Other names: Eylea

Primary outcomes

  1. Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept

    Time frame: Week 24

    Timing of supplemental injection

Secondary outcomes

  1. Change in best corrected visual acuity (BCVA)

    Time frame: Week 24

    Changes in BCVA

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)

Acronym: VERONA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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