Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (DAVIO2)

February 21, 2024 updated by: EyePoint Pharmaceuticals, Inc.

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

This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • EyePoint Investigative Site
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • EyePoint Investigative Site
    • California
      • Beverly Hills, California, United States, 90211
        • EyePoint Investigative Site
      • Campbell, California, United States, 95008
        • EyePoint Investigative Site
      • Encino, California, United States, 91436
        • EyePoint Investigative Site
      • Fullerton, California, United States, 92835
        • EyePoint Investigative Site
      • Glendale, California, United States, 91203
        • EyePoint Investigative Site
      • Huntington Beach, California, United States, 92647
        • EyePoint Investigative Site
      • Irvine, California, United States, 92697
        • EyePoint Investigative Site
      • Pasadena, California, United States, 91107
        • EyePoint Investigative Site
      • Poway, California, United States, 92064
        • EyePoint Investigative Site
      • Redlands, California, United States, 92373
        • EyePoint Investigative Site
      • Sacramento, California, United States, 95825
        • EyePoint Investigative Site
      • Walnut Creek, California, United States, 94598
        • EyePoint Investigative Site
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • EyePoint Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • EyePoint Investigative Site
      • Coral Springs, Florida, United States, 33067
        • EyePoint Investigative Site
      • Lakeland, Florida, United States, 33805
        • EyePoint Investigative Site
      • Melbourne, Florida, United States, 32901
        • EyePoint Investigative Site
      • Miami, Florida, United States, 33143
        • EyePoint Investigative Site
      • Pensacola, Florida, United States, 32503
        • EyePoint Investigative Site
      • Saint Petersburg, Florida, United States, 33711
        • EyePoint Investigative Site
      • Sarasota, Florida, United States, 34239
        • EyePoint Investigative Site
      • Tampa, Florida, United States, 33609
        • EyePoint Investigative Site
      • Winter Haven, Florida, United States, 33880
        • EyePoint Investigative Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • EyePoint Investigative Site
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • EyePoint Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • EyePoint Investigative Site
      • Lemont, Illinois, United States, 60439
        • EyePoint Investigative Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • EyePoint Investigative Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • EyePoint Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • EyePoint Investigative Site
      • Hagerstown, Maryland, United States, 21740
        • EyePoint Investigative Site
      • Owings Mills, Maryland, United States, 21117
        • EyePoint Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • EyePoint Investigative Site
      • Springfield, Massachusetts, United States, 01107
        • EyePoint Investigative Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49446
        • EyePoint Investigative Site
      • Saint Louis, Michigan, United States, 55416
        • EyePoint Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • EyePoint Investigative Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • EyePoint Investigative Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • EyePoint Investigative Site
    • New York
      • Great Neck, New York, United States, 11021
        • EyePoint Investigative Site
      • Hauppauge, New York, United States, 11788
        • EyePoint Investigative Site
      • Liverpool, New York, United States, 13088
        • EyePoint Investigative Site
      • Shirley, New York, United States, 11967
        • EyePoint Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • EyePoint Investigative Site
      • Wake Forest, North Carolina, United States, 27587
        • EyePoint Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • EyePoint Investigative Site
      • Portland, Oregon, United States, 97239
        • EyePoint Investigative Site
      • Springfield, Oregon, United States, 97488
        • EyePoint Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • EyePoint Investigative Site
      • West Columbia, South Carolina, United States, 29169
        • EyePoint Investigative Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • EyePoint Investigative Site
      • Nashville, Tennessee, United States, 37203
        • EyePoint Investigative Site
    • Texas
      • Abilene, Texas, United States, 79606
        • EyePoint Investigative Site
      • Austin, Texas, United States, 78750
        • EyePoint Investigative Sites
      • Dallas, Texas, United States, 75231
        • EyePoint Investigative Site
      • Houston, Texas, United States, 77025
        • EyePoint Investigative Sites
      • McAllen, Texas, United States, 78503
        • EyePoint Investigative Site
      • Plano, Texas, United States, 75075
        • EyePoint Investigative Site
      • San Antonio, Texas, United States, 78240
        • EyePoint Investigative Site
      • The Woodlands, Texas, United States, 77384
        • EyePoint Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • EyePoint Investigative Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • EyePoint Investigative Site
      • Lynchburg, Virginia, United States, 24502
        • EyePoint Investigative Site
      • Warrenton, Virginia, United States, 20186
        • EyePoint Investigative Site
    • Washington
      • Silverdale, Washington, United States, 98383
        • EyePoint Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
  • Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
  • BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.

Exclusion Criteria:

  • Central subfield thickness (CST) > 350 µm in the study eye at the Screening Visit or Day 1.
  • Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma).
  • Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EYP-1901 2060 ug
EYP-1901 2060 ug, single dose
Drug: Eyp-1901
Intravitreal Injection
Experimental: EYP-1901 3090 ug
EYP-1901 3090 ug, single dose
Drug: Eyp-1901
Intravitreal Injection
Active Comparator: Aflibercept
Aflibercept 2 mg [0.05mL] every 8 weeks
Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Intravitreal Injection
Other Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average change in best corrected visual acuity (BCVA)
Time Frame: Week 28 and Week 32
Week 28 and Week 32

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in best corrected visual acuity (BCVA)
Time Frame: Baseline, Week 56
Baseline, Week 56
Mean change in central retinal thickness on optical coherence tomography (OCT)
Time Frame: Baseline, Week 56
Baseline, Week 56
Number of rescue injections
Time Frame: Week 56
Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyePoint Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2022

Primary Completion (Actual)

November 7, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-1901-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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