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

NCT ID: NCT06668064

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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Conditions

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Wet Age Related Macular Degeneration wAMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EYP-1901 2686 µg

EYP-1901

Group Type EXPERIMENTAL

EYP-1901

Intervention Type DRUG

Intravitreal Injection

Aflibercept

Group Type ACTIVE_COMPARATOR

Aflibercept (2.0 mg)

Intervention Type DRUG

Intravitreal Injection

Interventions

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EYP-1901

Intravitreal Injection

Intervention Type DRUG

Aflibercept (2.0 mg)

Intravitreal Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EyePoint Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retinal Research Institute, LLC

Phoenix, Arizona, United States

Site Status

Retina Partners of Northwest Arkansas

Springdale, Arkansas, United States

Site Status

California Retina Consultants

Bakersfield, California, United States

Site Status

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Macula and Retina Institute

Glendale, California, United States

Site Status

Gavin Herbert Eye Institute

Irvine, California, United States

Site Status

Retina Consultants San Diego

Poway, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

Retinal Consultants Medical Group

Sacramento, California, United States

Site Status

West Coast Retina Medical Group

San Francisco, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

American Institute of Research

Whittier, California, United States

Site Status

RSC Research, PLLC

Denver, Colorado, United States

Site Status

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, United States

Site Status

Advanced Vision Institute

Longmont, Colorado, United States

Site Status

Connecticut Eye Consultants, P.C.

Danbury, Connecticut, United States

Site Status

SightSera Clinical Research LLC

Greenwich, Connecticut, United States

Site Status

Retina Group of New England, PC

Waterford, Connecticut, United States

Site Status

Advanced Research, LLC

Deerfield Beach, Florida, United States

Site Status

Vitreo Retinal Associates

Gainesville, Florida, United States

Site Status

Florida Retina Consultants

Lakeland, Florida, United States

Site Status

Florida Retina Institute

Orlando, Florida, United States

Site Status

Retina Specialty Institute

Pensacola, Florida, United States

Site Status

Eye Associates of Pinellas

Pinellas Park, Florida, United States

Site Status

Retina Group of Florida

Sarasota, Florida, United States

Site Status

MedEye Associates

South Miami, Florida, United States

Site Status

Retina Specialists of Tampa

Tampa, Florida, United States

Site Status

Retina Vitreous Associates of Florida

Tampa, Florida, United States

Site Status

Center for Retina & Macular Disease

Winter Haven, Florida, United States

Site Status

Gerogia Retina

Marietta, Georgia, United States

Site Status

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

Retina Associates

Elmhurst, Illinois, United States

Site Status

University Retina and Macula Associates

Lemont, Illinois, United States

Site Status

Midwest Eye Institute

Carmel, Indiana, United States

Site Status

Retina Associates LLC

Lenexa, Kansas, United States

Site Status

Maine Eye Center

Portland, Maine, United States

Site Status

The Retina Care Center

Baltimore, Maryland, United States

Site Status

Retina Groups of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

Retina Specialists

Towson, Maryland, United States

Site Status

Ophthalmic Consultants of Boston OCB - Boston

Boston, Massachusetts, United States

Site Status

New England Retina Consultants

Springfield, Massachusetts, United States

Site Status

Retina Associates of Michigan

Grand Blanc, Michigan, United States

Site Status

Foundation for Vision Research

Grand Rapids, Michigan, United States

Site Status

Deep Blue Retina Clinical Research PLLC

Southaven, Mississippi, United States

Site Status

The Retina Institute

St Louis, Missouri, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

NJ Retina

Teaneck, New Jersey, United States

Site Status

NJ Retina

Toms River, New Jersey, United States

Site Status

Vision Research Center at Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Site Status

Retina Vitreous Surgeons of CNY, PC

Liverpool, New York, United States

Site Status

Retina Associates of Western NY, PC

Rochester, New York, United States

Site Status

Retina Consultants PLLC

Slingerlands, New York, United States

Site Status

Western Carolina Retinal Associates, PA

Asheville, North Carolina, United States

Site Status

Cape Fear Retinal Associates, PC

Wilmington, North Carolina, United States

Site Status

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

Winston-Salem, North Carolina, United States

Site Status

Midwest Retina, Inc.

Dublin, Ohio, United States

Site Status

Tulsa Retina Consultant

Tulsa, Oklahoma, United States

Site Status

Verum Research LLC

Eugene, Oregon, United States

Site Status

Erie Retina Research

Erie, Pennsylvania, United States

Site Status

Eye Care Specialists - Kingston Location

Kingston, Pennsylvania, United States

Site Status

Retina Consultants

Charleston, South Carolina, United States

Site Status

Palmetto Retina Center

Florence, South Carolina, United States

Site Status

Retina Consultants of Carolina P.A

Greenville, South Carolina, United States

Site Status

Charles Retina Institute

Germantown, Tennessee, United States

Site Status

Retina Research Institute of Texas Integrated Clinical Research

Abilene, Texas, United States

Site Status

Retina and Vitreous of Texas

Bellaire, Texas, United States

Site Status

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

Bellaire, Texas, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

Texas Retina Associates

Plano, Texas, United States

Site Status

San Antonio Eye Center

San Antonio, Texas, United States

Site Status

Retinal Consultants of Texas

San Antonio, Texas, United States

Site Status

Retina Center of Texas

Southlake, Texas, United States

Site Status

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status

Tyler Retina Consultants

Tyler, Texas, United States

Site Status

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Site Status

Retina Associates of Utah

Salt Lake City, Utah, United States

Site Status

Rocky Mountain Retina Consultants

Salt Lake City, Utah, United States

Site Status

Salt Lake Retina

West Jordan, Utah, United States

Site Status

The Retina Group of Washington

Fairfax, Virginia, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Retina Associates, P.C.

Winchester, Virginia, United States

Site Status

University of Wisconsin School of Medicine and Public Health (UWSMPH)

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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EYP-1901-301

Identifier Type: -

Identifier Source: org_study_id

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