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 (wAMD)

September 2, 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

  • Brazil
      • Aracaju, Brazil
        • Retina Prime at Jardim Europa Medical Center
      • Blumenau, Brazil
        • Centro Brasileiro de Pesquisa Clinica - Blumenau
      • Sorocaba, Brazil
        • Hospital Oftalmológico de Sorocaba (Centro de Estudos)
      • São Paulo, Brazil
        • Clínica Oftalmológica São Lucas - Retina Clinic
      • São Paulo, Brazil
        • Hospital de Olhos Oeste Paulista
  • Czechia
      • Náchod, Czechia
        • VISUS, spol s.r.o.
      • Prague, Czechia
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia
        • Axon Clinical, s.r.o.
  • Germany
      • Cologne, Germany
        • St Elisabeth Krankenhaus
  • Hungary
      • Budapest, Hungary
        • Budapest Retina Associates
      • Budapest, Hungary
        • Bajcsy-Zsilinszky Korhaz es Rendelointezet
      • Debrecen, Hungary
        • Debreceni Egyetem KK Szemklinika
      • Pécs, Hungary
        • Ganglion Medical Center
  • India
      • Ahmedabad, India
        • Rising Retina Clinic
      • Kolkata, India
        • Netralayam VIP
      • Miraj, India
        • Shanti Saroj Netralay
      • Mumbai, India
        • Shroff Eye Hospital
      • Mumbai, India
        • K. B. Haji Bachooali Charitable Ophthalmic & E.N.T. Hospital
      • Varanasi, India
        • Netrodaya - The Eye City
  • Israel
      • Be’er Ya‘aqov, Israel
        • Shamir Medical Center Ophthalmology Out Patient Clinic
      • Haifa, Israel
        • Carmel Medical Center
      • Haifa, Israel
        • Bnai Zion Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center Ophthalmology Department
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • The Tel-Aviv Sourasky Medical Centre
  • Poland
      • Bydgoszcz, Poland
        • OFTALMIKA Sp. z o.o
      • Krakow, Poland
        • Szpital sw. Rozy- obsolete; New Name: Szpital Św. Róży sp. z o.o.
      • Lublin, Poland
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
      • Olsztyn, Poland
        • Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o
      • Tarnów, Poland
        • Centrum Medyczne UNO-MED
      • Warsaw, Poland
        • Piasta 47 Centrum Medyczne
      • Warsaw, Poland
        • Warszawski Szpital Okulistyczny
  • Slovakia
      • Banská Bystrica, Slovakia
        • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
  • United Kingdom
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Associated Retina Consultans
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants - Phoenix
      • Phoenix, Arizona, United States, 85050
        • Phoenix Retina Clinical Trials, LLC
      • Scottsdale, Arizona, United States, 85255
        • Retina Macula Institute of Arizona
    • California
      • Arcadia, California, United States, 91006
        • Win Retina
      • Beverly Hills, California, United States, 90211
        • Doctor Retina, PC
      • Encino, California, United States, 91436
        • The Retina Partners
      • Fullerton, California, United States, 92835
        • RCOC Clinical Research Institute Inc.
      • Glendale, California, United States, 91204
        • Global Research Management, Inc.
      • Huntington Beach, California, United States, 92647
        • Atlantis Eyecare
      • Long Beach, California, United States, 90807
        • South Coast Retina Center
      • Modesto, California, United States, 95356
        • Retinal Consultants Medical Group
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group INC.
      • Oakland, California, United States, 94611
        • Kaiser Permanente
      • Oxnard, California, United States, 93036
        • California Retina Consultants Oxnard Office
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Redlands, California, United States, 92373
        • California Eye Specialists Medical Group, Inc.
      • Sacramento, California, United States, 95825
        • VRMG Inc
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
      • Denver, Colorado, United States, 80210
        • RSC Research, PLLC
      • Fort Collins, Colorado, United States, 80528
        • Eye Center of Northern Colorado, PC
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants, P.C.
      • Greenwich, Connecticut, United States, 06830
        • SightSera Clinical Research LLC
    • Florida
      • Clearwater, Florida, United States, 33761
        • Blue Ocean Clinical Research
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Largo, Florida, United States, 33770
        • The Eye Institute of West Florida
      • Palm Beach Gardens, Florida, United States, 45674
        • Retina Care Specialists
      • Plantation, Florida, United States, 33324
        • Fort Lauderdale Eye Institute
      • South Miami, Florida, United States, 33143
        • MedEye Associates
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida - Saint Petersburg
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
      • Tampa, Florida, United States, 33618
        • Retina Specialists of Tampa
    • Illinois
      • Bloomington, Illinois, United States, 60616
        • Gailey Eye Clinic
      • Elmhurst, Illinois, United States, 60126
        • Retina Associates
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates, S.C.
      • Plainfield, Illinois, United States, 60586
        • 3RP/ Windy City Retina
    • Indiana
      • Carmel, Indiana, United States, 46032
        • AVRUC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Retina Associates New Orleans
      • West Monroe, Louisiana, United States, 71291
        • Haik Humble Eye Center
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Vitreo-Retinal Associates, PC
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Retina Associates of Michigan
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
      • Cherry Hill, New Jersey, United States, 08034
        • Mid Atlantic Retina
      • Edison, New Jersey, United States, 08820
        • NJ Retina
    • New York
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of CNY, PC
      • New York, New York, United States, 45604
        • NYC Retina
      • Rochester, New York, United States, 14620
        • Retina Associates of Western NY, PC
      • Westbury, New York, United States, 11590
        • VRCNY/Long Island Vitreoretinal Consultants
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • NC Retina Associates - Cary Research
      • Hickory, North Carolina, United States, 28602
        • Graystone Eye - Hickory Office
      • Wake Forest, North Carolina, United States, 27587
        • North Carolina Retina Associates
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center, PLLC
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Cascade Medical Research lnstitute, LLC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Wills Eye Physician Mid Atlantic Retina
    • South Dakota
      • Rapid City, South Dakota, United States, 45526
        • Black Hills Regional Eye Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina
    • Texas
      • Amarillo, Texas, United States, 79106
        • Panhandle Eye Group, LLP. - Southwest Retina Specialists
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78750
        • Austin Clinical Research LLC
      • Austin, Texas, United States, 45674
        • Austin Research Center for Retina
      • Burleson, Texas, United States, 76028
        • Star Vision Research
      • Houston, Texas, United States, 77027
        • Berkeley Eye Center
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute P.A.
      • Plano, Texas, United States, 75075
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas
      • San Antonio, Texas, United States, 78154
        • TX RCTX Retina Consultants of Texas
      • Tyler, Texas, United States, 75703
        • Tyler Retina Consultants
    • Virginia
      • Warrenton, Virginia, United States, 20186
        • Virginia Retina Center
    • Washington
      • Bellevue, Washington, United States, 98004
        • Pacific Northwest Retina

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)

November 27, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-1901-302

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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