A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) EYE201/MK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration (NVAMD)
Status: Recruiting
Location: See all (117) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye)
• The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment
Locations
United States
Arkansas
Retina Center of Arkansas
RECRUITING
Fayetteville
Retina Partners of Northwest Arkansas, PLLC
RECRUITING
Springdale
Arizona
Research Network Arizona / Retina Macula Institute of Arizona
RECRUITING
Scottsdale
California
Global Research Management, Inc.
RECRUITING
Glendale
Retinal Consultants Medical Group (Site 024)
RECRUITING
Modesto
Retina Consultants of Southern California (Site 043)
RECRUITING
Redlands
Retinal Consultants Medical Group (Site 020)
RECRUITING
Sacramento
Retinal Consultants Medical Group (Site 022)
RECRUITING
Sacramento
Florida
Florida Eye Clinic (Site 130)
RECRUITING
Altamonte Springs
Retina Group of Florida (Site 070)
RECRUITING
Fort Lauderdale
Vitreo Retinal Associates
RECRUITING
Gainesville
Florida Retina Institute
RECRUITING
Jacksonville
Florida Retina Consultants
RECRUITING
Lakeland
Retina Care Specialists
RECRUITING
Palm Beach Gardens
Fort Lauderdale Eye Institute (Site 042)
RECRUITING
Plantation
Retina Vitreous Associates of Florida (Site 049)
RECRUITING
St. Petersburg
Southern Vitreoretinal Associates
RECRUITING
Tallahassee
Retina Associates of Florida, LLC
RECRUITING
Tampa
Retina Vitreous Associates of Florida
RECRUITING
Tampa
Wildwood Clinical Research / Florida Retina Institute
RECRUITING
Wildwood
Illinois
Illinois Retina Associates
RECRUITING
Oak Park
Springfield Clinic
RECRUITING
Springfield
Indiana
Associated Vitreoretinal and Uveitis Consultants
RECRUITING
Carmel
Midwest Eye Institute
RECRUITING
Carmel
Maryland
Cumberland Valley Retina Consultants (Site 007)
RECRUITING
Hagerstown
Michigan
Foundation for Vision Research (Site 073)
RECRUITING
Grand Rapids
Minnesota
Retina Consultants of Minnesota
RECRUITING
Saint Louis Park
Mississippi
Retina Specialists of Mississippi
RECRUITING
Hattiesburg
Mississippi Retina Associates (Site 084)
RECRUITING
Madison
North Carolina
Piedmont Retina Specialists - Greensboro
RECRUITING
Greensboro
North Carolina Retina Associates
RECRUITING
Greenville
Piedmont Retina Specialists - Winston-Salem
RECRUITING
Winston-salem
New Jersey
Mid Atlantic Retina
RECRUITING
Cherry Hill
New Mexico
Vision Research Center Eye Associates of New Mexico
RECRUITING
Albuquerque
New York
ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105)
RECRUITING
Hauppauge
Retina Vitreous Surgeons of CNY, PC (Site 033)
RECRUITING
Liverpool
Ohio
Cincinnati Eye Institute (Site 133)
RECRUITING
Cincinnati
Oklahoma
Retina Vitreous Center
RECRUITING
Edmond
Tulsa Retina Consultants
RECRUITING
Tulsa
Oregon
EyeHealth Northwest
RECRUITING
Portland
Retina Northwest, PC
RECRUITING
Portland
Pennsylvania
Mid Atlantic Retina (Site 050)
RECRUITING
Bethlehem
South Carolina
Palmetto Retina Center
RECRUITING
Aiken
Charleston Neuroscience Institute - Bluffton (Site 124)
RECRUITING
Bluffton
Charleston Neuroscience Institute (Site 104)
RECRUITING
Charleston
Charleston Neuroscience Institute (CNI) d/b/a Retina Consultants of South Carolina
RECRUITING
Mt. Pleasant
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Texas
Retina Research Institute of Texas (Site 010)
RECRUITING
Abilene
Southwest Retina Specialists
RECRUITING
Amarillo
Texas Retina Associates
RECRUITING
Arlington
Austin Research Center for Retina
RECRUITING
Austin
Austin Retina Associates (Site 012)
RECRUITING
Austin
Retina & Vitreous of Texas
RECRUITING
Bellaire
Texas Retina Associates
RECRUITING
Dallas
Texas Retina (Site 037)
RECRUITING
Plano
Retina Center of Texas
RECRUITING
Southlake
Retina Consultants of Texas (Site 014)
RECRUITING
The Woodlands
Strategic Clinical Research Group
RECRUITING
Weatherford
Utah
Retina Associates of Utah
RECRUITING
Salt Lake City
Virginia
Piedmont Eye Center (Site 054)
RECRUITING
Lynchburg
Washington
Pacific Northwest Retina (Site 112)
RECRUITING
Burlington
Spokane Eye Clinical Research (Site 075)
RECRUITING
Spokane
Wisconsin
Eye Clinic of Wisconsin
RECRUITING
Wausau
West Virginia
Retina Consultants, PLLC
RECRUITING
Charleston
Other Locations
Argentina
Centro de Ojos Loria SRL (Site 312)
RECRUITING
Buenos Aires
Centro de Ojos Quilmes
RECRUITING
Buenos Aires
Centro Oftalmologico Dr Charles y Asociados (Site 300)
RECRUITING
Buenos Aires
Centro Oftalmológico Dr. Zas
RECRUITING
Buenos Aires
Clinica Privada de Ojos
RECRUITING
Buenos Aires
Fundacion Jorge Zambrano para la investigación, diagnostivo y tratamiento de enfermedades oculares (Site 302)
RECRUITING
Buenos Aires
Instituto Oftalmologico de Buenos Aires SA (Site 306)
RECRUITING
Buenos Aires
RSresearch (Site 308)
RECRUITING
Buenos Aires
Hospital Britanico- Microcentro
RECRUITING
Cdad. Autónoma De Buenos Aires
Instituto Donato
RECRUITING
Cdad. Autónoma De Buenos Aires
Centro Privado de Ojos Romagosa SA (Site 307)
RECRUITING
Córdoba
Instituto de Microcirugía Ocular Córdoba (IMOC S.R.L) (Site 305)
RECRUITING
Córdoba
Centrovision Clinica Oftalmologica
RECRUITING
Mendoza
Oftar Centro De Oftalmología en Mendoza
RECRUITING
Mendoza
Grupo Laser Vision (Rosario Eximer Laser Vision SA)
RECRUITING
Rosario
Microcirugia Ocular Rosario (Site 310)
RECRUITING
Rosario
Oftalmología Global (Centro Médico Oftalmología Global) (Site 304)
RECRUITING
Rosario
Centro de la Visión
RECRUITING
Salta
Centro de la Visión (Site 309)
RECRUITING
Salta
Instituto Zeman Bardeci (Site 311)
RECRUITING
Salta
Australia
Eye Clinic Albury Wodonga (Site 425)
RECRUITING
Albury
Retina and Eye Consultants
RECRUITING
Hurstville
Launceston Eye Doctors
RECRUITING
Launceston
Marsden Eye Specialists (Site 420)
RECRUITING
Parramatta
Marsden Eye Specialists (Site 423)
RECRUITING
Strathfield
Sydney Eye Hospital (Site 426)
RECRUITING
Sydney
Sydney Retina Clinic and Day Surgery (Site 424)
RECRUITING
Sydney
Estonia
Silmalaser OÜ
RECRUITING
Tallinn
Germany
Augenzentrum am St. Franziskus Hospital Münster
RECRUITING
Münster
Israel
Barzilai Medical Center
RECRUITING
Ashkelon
Carmel Medical Center (Site 704)
RECRUITING
Haifa
Rambam Health Corporation (Site 706)
RECRUITING
Haifa
Hadassah Medical Center Opthalmology Department (Site 701)
RECRUITING
Jerusalem
Rabin Medical Center (Site 700)
RECRUITING
Petah Tikva
Sheba Medical Center (Site 707)
RECRUITING
Ramat Gan
Kaplan Medical Center Ophthalmology Department (Site 705)
RECRUITING
Rehovot
Shamir Medical Center (Site 703)
RECRUITING
Ẕerifin
Latvia
P.Stradins clinical university hospital
RECRUITING
Riga
Riga East University hospital, clinical centre Bikernieki
RECRUITING
Riga
Northern Kurzeme Regional Hospital
RECRUITING
Ventspils
Poland
Oftalmika Sp. z o.o.
RECRUITING
Bydgoszcz
Klinika okulistyczna w Olsztynie - Centrum Diagnostyki i Mikrochirurgii Oka Lens
RECRUITING
Olsztyn
Puerto Rico
Centro Oftalmologico Metropolitano
RECRUITING
San Juan
Spain
Clinica de Oftalmologia Barraquer
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron - despacho de coordinación de oftalmología. Planta 8, Edifici General
RECRUITING
Barcelona
Hospital Universitario Puerta de Hierro - Majadahonda
RECRUITING
Madrid
Switzerland
University Hospital Basel, Eye Clinic
RECRUITING
Basel
Swiss Eye Institute and Berner Augenklinik
RECRUITING
Bern
Vista Augenklinik Binningen
RECRUITING
Binnigen
Fondation Asile des aveugles (Hôpital Ophtalmique Jules-Gonin)
RECRUITING
Lausanne
Stadtspital Zurich Triemli Forschungszentrum Augenklinik
RECRUITING
Zurich
United Kingdom
University Hospitals of Leicester NHS Trust (Site 209)
RECRUITING
Leicester
London North West University Healthcare NHS Trust (LNWH) (Site 201)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 960
Treatments
Experimental: Tiespectus Low Dose
Participants receive 3 initial administrations of tiespectus low dose every 4 weeks (Q4W), then continue to receive tiespectus low dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92.
Experimental: Tiespectus High Dose
Participants receive 3 initial administrations of tiespectus high dose Q4W, then continue to receive tiespectus high dose Q8W until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 92
Active_comparator: Aflibercept 2 mg
Participants receive 3 initial administrations of aflibercept, then continue to receive aflibercept Q8W until week 92
Related Therapeutic Areas
Sponsors
Leads: EyeBiotech Ltd.