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

Primary Purpose

Diabetic Macular Edema

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EYP-1901
Aflibercept 2Mg/0.05Ml Inj,Oph
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, EYP-1901, EyePoint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    EYP-1901 1340 µg

    EYP-1901 2680 µg

    Aflibercept

    Arm Description

    EYP-1901 1340 µg, single dose

    EYP-1901 2680 µg, single dose

    Aflibercept 2 mg/0.05mL solution, single dose

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change in best corrected visual acuity (BCVA)

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    EyePoint Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099184
    Brief Title
    Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
    Acronym
    VERONA
    Official 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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2024 (Anticipated)
    Primary Completion Date
    January 15, 2025 (Anticipated)
    Study Completion Date
    January 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EyePoint Pharmaceuticals, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema
    Keywords
    DME, EYP-1901, EyePoint

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Single (Participant)
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EYP-1901 1340 µg
    Arm Type
    Experimental
    Arm Description
    EYP-1901 1340 µg, single dose
    Arm Title
    EYP-1901 2680 µg
    Arm Type
    Experimental
    Arm Description
    EYP-1901 2680 µg, single dose
    Arm Title
    Aflibercept
    Arm Type
    Active Comparator
    Arm Description
    Aflibercept 2 mg/0.05mL solution, single dose
    Intervention Type
    Drug
    Intervention Name(s)
    EYP-1901
    Intervention Description
    Intravitreal Injection
    Intervention Type
    Drug
    Intervention Name(s)
    Aflibercept 2Mg/0.05Ml Inj,Oph
    Intervention Description
    Intravitreal Injection
    Primary Outcome Measure Information:
    Title
    Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
    Time Frame
    Week 24
    Secondary Outcome Measure Information:
    Title
    Change in best corrected visual acuity (BCVA)
    Time Frame
    Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).

    12. IPD Sharing Statement

    Learn more about this trial

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

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