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

Last updated: March 3, 2025
Sponsor: EyePoint Pharmaceuticals, Inc.
Overall Status: Completed

Phase

2

Condition

Diabetic Macular Edema

Macular Edema

Diabetic Retinopathy

Treatment

EYP-1901

Aflibercept 2Mg/0.05Ml Inj,Oph

Clinical Study ID

NCT06099184
EYP-1901-202
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of diabetes mellitus in the study eye, with disease onset any time priorto the Screening Visit

  • Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months inthe study eye at least 8 weeks prior to the Screening Visit.

  • BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion

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).

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: EYP-1901
Phase: 2
Study Start date:
January 15, 2024
Estimated Completion Date:
October 24, 2024

Study Description

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

Connect with a study center

  • EyePoint Investigative Site

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • EyePoint Investigative Site

    Lemont, Illinois 60439
    United States

    Site Not Available

  • EyePoint Investigative Site

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • EyePoint Investigative Site

    Reno, Nevada 89502
    United States

    Site Not Available

  • EyePoint Investigative Site

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • EyePoint Investigative Site

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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