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 (wAMD)

May 1, 2026 updated by: EyePoint Pharmaceuticals, Inc.

A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

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
        • Retinal Research Institute, LLC
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Retina Partners of Northwest Arkansas
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Glendale, California, United States, 91203
        • Macula and Retina Institute
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
      • Whittier, California, United States, 95008
        • American Institute of Research
    • Colorado
      • Denver, Colorado, United States, 80210
        • RSC Research, PLLC
      • Fort Collins, Colorado, United States, 80528
        • Eye Center of Northern Colorado, PC
      • Longmont, Colorado, United States, 80503
        • Advanced Vision Institute
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants, P.C.
      • Greenwich, Connecticut, United States, 06830
        • SightSera Clinical Research LLC
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England, PC
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Advanced Research, LLC
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Pinellas Park, Florida, United States, 33782
        • Eye Associates of Pinellas
      • South Miami, Florida, United States, 33143
        • MedEye Associates
      • Tampa, Florida, United States, 33617
        • Retina Vitreous Associates of Florida
      • Tampa, Florida, United States, 33544
        • Retina Specialists of Tampa
      • Winter Haven, Florida, United States, 33880
        • Center for Retina & Macular Disease
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gerogia Retina
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Retina Associates
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Midwest Eye Institute
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Retina Associates LLC
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Eye Center
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center
      • Chevy Chase, Maryland, United States, 20815
        • Retina Groups of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Towson, Maryland, United States, 21204
        • Retina Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston OCB - Boston
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Retina Associates of Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Foundation for Vision Research
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Deep Blue Retina Clinical Research PLLC
    • Missouri
      • St Louis, Missouri, United States, 63128
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • NJ Retina
      • Toms River, New Jersey, United States, 08755
        • NJ Retina
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center at Eye Associates of New Mexico
    • New York
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of CNY, PC
      • Rochester, New York, United States, 14620
        • Retina Associates of Western NY, PC
      • Slingerlands, New York, United States, 12159
        • Retina Consultants PLLC
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associates, PA
      • Wilmington, North Carolina, United States, 28401
        • Cape Fear Retinal Associates, PC
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Retina Specialists, P.A. - Winston-Salem Office
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa Retina Consultant
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research LLC
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists - Kingston Location
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Retina Consultants
      • Florence, South Carolina, United States, 29169
        • Palmetto Retina Center
      • Greenville, South Carolina, United States, 29605
        • Retina Consultants of Carolina P.A
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas Integrated Clinical Research
      • Bellaire, Texas, United States, 77401
        • Retina and Vitreous of Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Plano, Texas, United States, 75075
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
      • Tyler, Texas, United States, 75703
        • Tyler Retina Consultants
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
      • West Jordan, Utah, United States, 84088
        • Salt Lake Retina
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • The Retina Group of Washington
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center
      • Winchester, Virginia, United States, 22601
        • Retina Associates, P.C.
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin School of Medicine and Public Health (UWSMPH)

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening 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 Snellen equivalent) 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-VEGF IVT 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 study eye prior to the Screening Visit.

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 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aflibercept
Drug: Aflibercept (2.0 mg)
Intravitreal Injection
Experimental: EYP-1901 2686 µg
EYP-1901
Drug: EYP-1901
Intravitreal Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average change in best corrected visual acuity (BCVA)
Time Frame: Weeks 52 and 56
Weeks 52 and 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of injection burden
Time Frame: Week 56
Week 56
Average change in best corrected visual acuity (BCVA)
Time Frame: Week 96
Week 96

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)

October 22, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-1901-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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