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

NCT ID: NCT06683742

Last Updated: 2026-02-03

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

2024-11-27

Study Completion Date

2027-10-31

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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Associated Retina Consultans

Gilbert, Arizona, United States

Site Status

Associated Retina Consultants - Phoenix

Phoenix, Arizona, United States

Site Status

Phoenix Retina Clinical Trials, LLC

Phoenix, Arizona, United States

Site Status

Retina Macula Institute of Arizona

Scottsdale, Arizona, United States

Site Status

Win Retina

Arcadia, California, United States

Site Status

Doctor Retina, PC

Beverly Hills, California, United States

Site Status

The Retina Partners

Encino, California, United States

Site Status

RCOC Clinical Research Institute Inc.

Fullerton, California, United States

Site Status

Global Research Management, Inc.

Glendale, California, United States

Site Status

Atlantis Eyecare

Huntington Beach, California, United States

Site Status

South Coast Retina Center

Long Beach, California, United States

Site Status

Retinal Consultants Medical Group

Modesto, California, United States

Site Status

Northern California Retina Vitreous Associates Medical Group INC.

Mountain View, California, United States

Site Status

Kaiser Permanente

Oakland, California, United States

Site Status

California Retina Consultants Oxnard Office

Oxnard, California, United States

Site Status

Retina Consultants San Diego

Poway, California, United States

Site Status

California Eye Specialists Medical Group, Inc.

Redlands, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

SCPMG/Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Site Status

VRMG Inc

Sacramento, 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

Macula Retina Vitreous Research Institute

Torrance, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 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

Colorado Retina Associates

Lakewood, 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

Blue Ocean Clinical Research

Clearwater, Florida, United States

Site Status

Advanced Research, LLC

Deerfield Beach, Florida, United States

Site Status

Rand Eye Institute

Deerfield Beach, Florida, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

The Eye Institute of West Florida

Largo, Florida, United States

Site Status

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Site Status

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status

MedEye Associates

South Miami, Florida, United States

Site Status

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, United States

Site Status

East Florida Eye Institute

Stuart, Florida, United States

Site Status

Retina Specialists of Tampa

Tampa, Florida, United States

Site Status

Georgia Retina

Marietta, Georgia, United States

Site Status

Gailey Eye Clinic

Bloomington, Illinois, United States

Site Status

Retina Associates

Elmhurst, Illinois, United States

Site Status

Illinois Retina Associates, S.C.

Oak Park, Illinois, United States

Site Status

Red River Research Partners

Plainfield, Illinois, United States

Site Status

AVRUC

Carmel, Indiana, United States

Site Status

Retina Associates of Kentucky

Lexington, Kentucky, United States

Site Status

The Eye Care Institute

Louisville, Kentucky, United States

Site Status

Retina Associates New Orleans

Metairie, Louisiana, United States

Site Status

Haik Humble Eye Center

West Monroe, Louisiana, United States

Site Status

The Retina Care Center

Baltimore, Maryland, United States

Site Status

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Site Status

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, United States

Site Status

Retina Associates of Michigan

Grand Blanc, Michigan, United States

Site Status

Discover Vision Center

Independence, Missouri, United States

Site Status

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Site Status

Mid Atlantic Retina

Cherry Hill, New Jersey, United States

Site Status

NJ Retina

Edison, New Jersey, United States

Site Status

NJ Retina

Toms River, New Jersey, United States

Site Status

Retina Vitreous Surgeons of CNY, PC

Liverpool, New York, United States

Site Status

NYC Retina

New York, New York, United States

Site Status

Retina Associates of Western NY, PC

Rochester, New York, United States

Site Status

VRCNY/Long Island Vitreoretinal Consultants

Westbury, New York, United States

Site Status

NC Retina Associates - Cary Research

Cary, North Carolina, United States

Site Status

Graystone Eye - Hickory Office

Hickory, North Carolina, United States

Site Status

North Carolina Retina Associates

Wake Forest, North Carolina, United States

Site Status

Retina Vitreous Center, PLLC

Edmond, Oklahoma, United States

Site Status

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Site Status

Casey Eye Institute at OHSU

Portland, Oregon, United States

Site Status

Cascade Medical Research lnstitute, LLC

Springfield, Oregon, United States

Site Status

Wills Eye Physician Mid Atlantic Retina

Bethlehem, Pennsylvania, United States

Site Status

Erie Retina Research

Erie, Pennsylvania, United States

Site Status

Retina Vitreous Consultants (RVC) - Monroeville

Monroeville, Pennsylvania, United States

Site Status

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Tennessee Retina

Nashville, Tennessee, United States

Site Status

Panhandle Eye Group, LLP. - Southwest Retina Specialists

Amarillo, Texas, United States

Site Status

Texas Retina Associates

Arlington, Texas, United States

Site Status

Austin Research Center for Retina

Austin, Texas, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Austin Clinical Research LLC

Austin, Texas, United States

Site Status

TX RCTX Retina Consultants of Texas

Beaumont, Texas, United States

Site Status

Star Vision Research

Burleson, Texas, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Retina of North Texas

Dallas, Texas, United States

Site Status

Berkeley Eye Center

Houston, Texas, United States

Site Status

Retina Consultants of Texas

Katy, Texas, United States

Site Status

Valley Retina Institute P.A.

McAllen, Texas, United States

Site Status

Red River Research Partners, LLC

Plano, Texas, United States

Site Status

Texas Retina Associates

Plano, Texas, United States

Site Status

TX RCTX Retina Consultants of Texas

San Antonio, Texas, United States

Site Status

San Antonio Eye Center

San Antonio, Texas, United States

Site Status

Retina Associates of South Texas

San Antonio, Texas, United States

Site Status

Tyler Retina Consultants

Tyler, Texas, United States

Site Status

Retina Associates of Utah

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

Emerson Clinical Research Institute

Falls Church, Virginia, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Virginia Retina Center

Warrenton, Virginia, United States

Site Status

Pacific Northwest Retina

Bellevue, Washington, United States

Site Status

Eye Clinic Albury Wodonga

Albury, , Australia

Site Status

Marsden Eye Specialists

Parramatta, , Australia

Site Status

Sydney Retina Clinic and Day Surgery

Sydney, , Australia

Site Status

Retina Prime at Jardim Europa Medical Center

Aracaju, , Brazil

Site Status

Centro Brasileiro de Pesquisa Clinica - Blumenau

Blumenau, , Brazil

Site Status

Clínica Oftalmológica São Lucas - Retina Clinic

São Paulo, , Brazil

Site Status

Hospital de Olhos Oeste Paulista

São Paulo, , Brazil

Site Status

UNIFESP - Hospital Sao Paulo

São Paulo, , Brazil

Site Status

Hospital Oftalmológico de Sorocaba (Centro de Estudos)

Sorocaba, , Brazil

Site Status

VISUS, spol s.r.o.

Náchod, , Czechia

Site Status

Axon Clinical, s.r.o.

Prague, , Czechia

Site Status

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status

St Elisabeth Krankenhaus

Cologne, , Germany

Site Status

Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, , Hungary

Site Status

Budapest Retina Associates

Budapest, , Hungary

Site Status

Debreceni Egyetem KK Szemklinika

Debrecen, , Hungary

Site Status

Ganglion Medical Center

Pécs, , Hungary

Site Status

Pecsi Tudomanyegyetem AOK

Pécs, , Hungary

Site Status

Rising Retina Clinic

Ahmedabad, , India

Site Status

Narayana Netralaya

Bengaluru, , India

Site Status

Netralayam VIP

Kolkata, , India

Site Status

Aravind Eye Hospital and Postgraduate Institute of Ophthalmology

Madurai, , India

Site Status

Shanti Saroj Netralay

Miraj, , India

Site Status

K. B. Haji Bachooali Charitable Ophthalmic & E.N.T. Hospital

Mumbai, , India

Site Status

Shroff Eye Hospital

Mumbai, , India

Site Status

Netrodaya - The Eye City

Varanasi, , India

Site Status

Shamir Medical Center Ophthalmology Out Patient Clinic

Be’er Ya‘aqov, , Israel

Site Status

Bnai Zion Medical Center

Haifa, , Israel

Site Status

Carmel Medical Center

Haifa, , Israel

Site Status

Hadassah University Hospital

Jerusalem, , Israel

Site Status

Meir Medical Center Ophthalmology Department

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

The Tel-Aviv Sourasky Medical Centre

Tel Aviv, , Israel

Site Status

OFTALMIKA Sp. z o.o

Bydgoszcz, , Poland

Site Status

Szpital sw. Rozy- obsolete; New Name: Szpital Św. Róży sp. z o.o.

Krakow, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, , Poland

Site Status

Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o

Olsztyn, , Poland

Site Status

Centrum Medyczne UNO-MED

Tarnów, , Poland

Site Status

Piasta 47 Centrum Medyczne

Warsaw, , Poland

Site Status

Warszawski Szpital Okulistyczny

Warsaw, , Poland

Site Status

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Banská Bystrica, , Slovakia

Site Status

CMO Bratislava

Bratislava, , Slovakia

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United States Australia Brazil Czechia Germany Hungary India Israel Poland Slovakia United Kingdom

Other Identifiers

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EYP-1901-302

Identifier Type: -

Identifier Source: org_study_id

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