A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56

Last updated: April 1, 2025
Sponsor: EyePoint Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Geographic Atrophy

Macular Degeneration

Treatment

EYP-1901

Aflibercept (2.0 mg)

Clinical Study ID

NCT06668064
EYP-1901-301
  • Ages > 50
  • All Genders

Study Summary

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previously treated or treatment naïve patients with a documented diagnosis of wAMDin the study eye, with onset of disease that began at any time prior to theScreening Visit.

  • Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellenequivalent) in the study eye at the Screening Visit and on Baseline (Day 1).

  • For previously-treated subjects, must have been treated with at least 2 anti-VEGFIVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab,or faricimab) in the previous 6 months for wAMD per standard of care in the studyeye prior to the Screening Visit.

Exclusion

Exclusion Criteria:

  • Subfoveal fibrosis, atrophy, or scarring in the center subfield.

  • BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: EYP-1901
Phase: 3
Study Start date:
October 22, 2024
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Retinal Research Institute, LLC

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • LUGANO Study Site

    Springdale, Arkansas 72764
    United States

    Active - Recruiting

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas 72764
    United States

    Active - Recruiting

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • LUGANO Study Site

    Glendale, California 91203
    United States

    Active - Recruiting

  • Macula and Retina Institute

    Glendale, California 91203
    United States

    Active - Recruiting

  • LUGANO Study Site

    Poway, California 92064
    United States

    Active - Recruiting

  • Retina Consultants San Diego

    Poway, California 92064
    United States

    Active - Recruiting

  • Retina Consultants of Southern California

    Redlands, California 92374
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95841
    United States

    Active - Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • LUGANO Study Site

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • American Institute of Research

    Whittier, California 95008
    United States

    Active - Recruiting

  • RSC Research, PLLC

    Denver, Colorado 80210
    United States

    Active - Recruiting

  • Eye Center of Northern Colorado, PC

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Advanced Vision Institute

    Longmont, Colorado 80503
    United States

    Active - Recruiting

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut 06810
    United States

    Active - Recruiting

  • LUGANO Study Site

    Danbury, Connecticut 06810
    United States

    Active - Recruiting

  • SightSera Clinical Research LLC

    Greenwich, Connecticut 06830
    United States

    Active - Recruiting

  • LUGANO Study Site

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Retina Group of New England, PC

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Advanced Research, LLC

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • LUGANO Study Site

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • Vitreo Retinal Associates

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • LUGANO Study Site

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Active - Recruiting

  • Retina Group of Florida

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • LUGANO Study Site

    South Miami, Florida 33143
    United States

    Active - Recruiting

  • MedEye Associates

    South Miami, Florida 33143
    United States

    Active - Recruiting

  • Retina Specialists of Tampa

    Tampa, Florida 33544
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida

    Tampa, Florida 33617
    United States

    Active - Recruiting

  • Center for Retina & Macular Disease

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Gerogia Retina

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • LUGANO Study Site

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Retina Consultants of Hawaii

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • LUGANO Study Site

    Aiea, Hawaii 96701
    United States

    Site Not Available

  • Retina Consultants of Hawaii

    Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Retina Associates

    Elmhurst, Illinois 60126
    United States

    Active - Recruiting

  • LUGANO Study Site

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • University Retina and Macula Associates

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • Midwest Eye Institute

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Retina Associates LLC

    Lenexa, Kansas 66215
    United States

    Active - Recruiting

  • Maine Eye Center

    Portland, Maine 04101
    United States

    Active - Recruiting

  • The Retina Care Center

    Baltimore, Maryland 21209
    United States

    Active - Recruiting

  • Retina Groups of Washington

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Retina Specialists

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • LUGANO Study Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston OCB - Boston

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • LUGANO Study Site

    Springfield, Massachusetts 01107
    United States

    Active - Recruiting

  • New England Retina Consultants

    Springfield, Massachusetts 01107
    United States

    Active - Recruiting

  • Retina Associates of Michigan

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Foundation for Vision Research

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • LUGANO Study Site

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • The Retina Institute

    St Louis, Missouri 63128
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • NJ Retina

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • NJ Retina

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • LUGANO Study Site

    Rochester, New York 14620
    United States

    Active - Recruiting

  • Retina Associates of Western NY, PC

    Rochester, New York 14620
    United States

    Active - Recruiting

  • Retina Consultants PLLC

    Singerlands, New York 12159
    United States

    Active - Recruiting

  • LUGANO Study Site

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Western Carolina Retinal Associates, PA

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Cape Fear Retinal Associates, PC

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • LUGANO Study Site

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Piedmont Retina Specialists, P.A. - Winston-Salem Office

    Winston Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Piedmont Retina Specialists, P.A. - Winston-Salem Office

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Tulsa Retina Consultant

    Tulsa, Oklahoma 74114
    United States

    Active - Recruiting

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • LUGANO Study Site

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Eye Care Specialists - Kingston Location

    Kingston, Pennsylvania 18704
    United States

    Active - Recruiting

  • LUGANO Study Site

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Retina Consultants

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Palmetto Retina Center

    Florence, South Carolina 29169
    United States

    Active - Recruiting

  • LUGANO Study Site

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Retina Consultants of Carolina P.A

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • LUGANO Study Site

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Retina Research Institute of Texas Integrated Clinical Research

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • LUGANO Study Site

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Retina and Vitreous of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • LUGANO Study Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Houston Eye Associates

    Houston, Texas 77025
    United States

    Active - Recruiting

  • Texas Retina Associates

    Plano, Texas 75075
    United States

    Active - Recruiting

  • LUGANO Study Site

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retinal Consultants of Texas

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • San Antonio Eye Center

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • LUGANO Study Site

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • LUGANO Study Site

    Tyler, Texas 75703
    United States

    Active - Recruiting

  • Tyler Retina Consultants

    Tyler, Texas 75703
    United States

    Active - Recruiting

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas 76087
    United States

    Active - Recruiting

  • LUGANO Study Site

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Retina Associates of Utah

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Salt Lake Retina

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • The Retina Group of Washington

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • LUGANO Study Site

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Retina Associates, P.C.

    Winchester, Virginia 22601
    United States

    Active - Recruiting

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