NCT06683742

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
17mo left

Started Nov 2024

Typical duration for phase_3

Geographic Reach
10 countries

125 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Nov 2024Oct 2027

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

November 8, 2024

Last Update Submit

May 1, 2026

Conditions

Keywords

Wet Age-related Macular DegenerationTyrosine Kinase InhibitorEYP-1901EyePoint

Outcome Measures

Primary Outcomes (1)

  • Average change in best corrected visual acuity (BCVA)

    Weeks 52 and 56

Secondary Outcomes (2)

  • Rate of injection burden

    Week 56

  • Average change in best corrected visual acuity (BCVA)

    Week 96

Study Arms (2)

EYP-1901 2686 µg

EXPERIMENTAL

EYP-1901

Drug: EYP-1901

Aflibercept

ACTIVE COMPARATOR
Drug: Aflibercept (2.0 mg)

Interventions

Intravitreal Injection

Aflibercept

Intravitreal Injection

EYP-1901 2686 µg

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subfoveal fibrosis, atrophy, or scarring in the center subfield.
  • BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (125)

Associated Retina Consultans

Gilbert, Arizona, 85297, United States

Location

Associated Retina Consultants - Phoenix

Phoenix, Arizona, 85020, United States

Location

Phoenix Retina Clinical Trials, LLC

Phoenix, Arizona, 85050, United States

Location

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Doctor Retina, PC

Beverly Hills, California, 90211, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

RCOC Clinical Research Institute Inc.

Fullerton, California, 92835, United States

Location

Global Research Management, Inc.

Glendale, California, 91204, United States

Location

Atlantis Eyecare

Huntington Beach, California, 92647, United States

Location

South Coast Retina Center

Long Beach, California, 90807, United States

Location

Retinal Consultants Medical Group

Modesto, California, 95356, United States

Location

Northern California Retina Vitreous Associates Medical Group INC.

Mountain View, California, 94040, United States

Location

Kaiser Permanente

Oakland, California, 94611, United States

Location

California Retina Consultants Oxnard Office

Oxnard, California, 93036, United States

Location

Retina Consultants San Diego

Poway, California, 92064, United States

Location

California Eye Specialists Medical Group, Inc.

Redlands, California, 92373, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

VRMG Inc

Sacramento, California, 95825, United States

Location

West Coast Retina Medical Group

San Francisco, California, 94109, United States

Location

Macula Retina Vitreous Research Institute

Torrance, California, 90503, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

Location

RSC Research, PLLC

Denver, Colorado, 80210, United States

Location

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, 80528, United States

Location

Colorado Retina Associates

Lakewood, Colorado, 80228, United States

Location

Connecticut Eye Consultants, P.C.

Danbury, Connecticut, 06810, United States

Location

SightSera Clinical Research LLC

Greenwich, Connecticut, 06830, United States

Location

Blue Ocean Clinical Research

Clearwater, Florida, 33761, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

Retina Care Specialists

Palm Beach Gardens, Florida, 45674, United States

Location

Fort Lauderdale Eye Institute

Plantation, Florida, 33324, United States

Location

MedEye Associates

South Miami, Florida, 33143, United States

Location

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, 33711, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Retina Specialists of Tampa

Tampa, Florida, 33618, United States

Location

Gailey Eye Clinic

Bloomington, Illinois, 60616, United States

Location

Retina Associates

Elmhurst, Illinois, 60126, United States

Location

Illinois Retina Associates, S.C.

Oak Park, Illinois, 60304, United States

Location

Red River Research Partners

Plainfield, Illinois, 60586, United States

Location

AVRUC

Carmel, Indiana, 46032, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Retina Associates New Orleans

Metairie, Louisiana, 70006, United States

Location

Haik Humble Eye Center

West Monroe, Louisiana, 71291, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

Location

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, 01605, United States

Location

Retina Associates of Michigan

Grand Blanc, Michigan, 48439, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Mid Atlantic Retina

Cherry Hill, New Jersey, 08034, United States

Location

NJ Retina

Edison, New Jersey, 08820, United States

Location

Retina Vitreous Surgeons of CNY, PC

Liverpool, New York, 13088, United States

Location

NYC Retina

New York, New York, 45604, United States

Location

Retina Associates of Western NY, PC

Rochester, New York, 14620, United States

Location

VRCNY/Long Island Vitreoretinal Consultants

Westbury, New York, 11590, United States

Location

NC Retina Associates - Cary Research

Cary, North Carolina, 27511, United States

Location

Graystone Eye - Hickory Office

Hickory, North Carolina, 28602, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Retina Vitreous Center, PLLC

Edmond, Oklahoma, 73013, United States

Location

Cascade Medical Research lnstitute, LLC

Springfield, Oregon, 97477, United States

Location

Wills Eye Physician Mid Atlantic Retina

Bethlehem, Pennsylvania, 18017, United States

Location

Retina Vitreous Consultants (RVC) - Monroeville

Monroeville, Pennsylvania, 45674, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 45526, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Panhandle Eye Group, LLP. - Southwest Retina Specialists

Amarillo, Texas, 79106, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Austin Research Center for Retina

Austin, Texas, 45674, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

TX RCTX Retina Consultants of Texas

Beaumont, Texas, 77707, United States

Location

Star Vision Research

Burleson, Texas, 76028, United States

Location

Retina of North Texas

Dallas, Texas, 75243, United States

Location

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Valley Retina Institute P.A.

McAllen, Texas, 78503, United States

Location

Texas Retina Associates

Plano, Texas, 75075, United States

Location

TX RCTX Retina Consultants of Texas

San Antonio, Texas, 78154, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78215, United States

Location

Retina Associates of South Texas

San Antonio, Texas, 78240, United States

Location

Tyler Retina Consultants

Tyler, Texas, 75703, United States

Location

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

The Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

Emerson Clinical Research Institute

Falls Church, Virginia, 22046, United States

Location

Virginia Retina Center

Warrenton, Virginia, 20186, United States

Location

Pacific Northwest Retina

Bellevue, Washington, 98004, United States

Location

Retina Prime at Jardim Europa Medical Center

Aracaju, Brazil

Location

Centro Brasileiro de Pesquisa Clinica - Blumenau

Blumenau, Brazil

Location

Clínica Oftalmológica São Lucas - Retina Clinic

São Paulo, Brazil

Location

Hospital de Olhos Oeste Paulista

São Paulo, Brazil

Location

Hospital Oftalmológico de Sorocaba (Centro de Estudos)

Sorocaba, Brazil

Location

VISUS, spol s.r.o.

Náchod, Czechia

Location

Axon Clinical, s.r.o.

Prague, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Location

St Elisabeth Krankenhaus

Cologne, Germany

Location

Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, Hungary

Location

Budapest Retina Associates

Budapest, Hungary

Location

Debreceni Egyetem KK Szemklinika

Debrecen, Hungary

Location

Ganglion Medical Center

Pécs, Hungary

Location

Rising Retina Clinic

Ahmedabad, India

Location

Netralayam VIP

Kolkata, India

Location

Shanti Saroj Netralay

Miraj, India

Location

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

Mumbai, India

Location

Shroff Eye Hospital

Mumbai, India

Location

Netrodaya - The Eye City

Varanasi, India

Location

Shamir Medical Center Ophthalmology Out Patient Clinic

Be’er Ya‘aqov, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Meir Medical Center Ophthalmology Department

Kfar Saba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

The Tel-Aviv Sourasky Medical Centre

Tel Aviv, Israel

Location

OFTALMIKA Sp. z o.o

Bydgoszcz, Poland

Location

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

Krakow, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, Poland

Location

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

Olsztyn, Poland

Location

Centrum Medyczne UNO-MED

Tarnów, Poland

Location

Piasta 47 Centrum Medyczne

Warsaw, Poland

Location

Warszawski Szpital Okulistyczny

Warsaw, Poland

Location

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Banská Bystrica, Slovakia

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Interventions

aflibercept

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

November 27, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-05

Locations