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 (66) 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
Arizona
Associated Retina Consultants - Gilbert
RECRUITING
Gilbert
California
The Retina Partners
RECRUITING
Encino
Northern California Retina Vitreous Associates Medical Group, Inc.
RECRUITING
Mountain View
Orange County Retina Medical Group
RECRUITING
Santa Ana
Colorado
Retina Consultants of Southern Colorado
RECRUITING
Colorado Springs
RSC Research LLC
RECRUITING
Denver
Retina Consultants of Southern Colorado
RECRUITING
Pueblo
Connecticut
Connecticut Eye Consultants, P.C.
RECRUITING
Danbury
Retina Consultants, P.C.
RECRUITING
Manchester
Retina Group of New England
RECRUITING
Waterford
Florida
Retina Group of Florida
RECRUITING
Fort Myers
Florida Retina Institute
RECRUITING
Orlando
Retina Group of Florida (Site 065)
RECRUITING
Sarasota
Center for Retina and Macular Disease (Site 062)
RECRUITING
Winter Haven
Iowa
Wolfe Eye Clinic
RECRUITING
West Des Moines
Illinois
Illinois Retina Associates
RECRUITING
Joliet
University Retina & Macula Associates, P.C.
RECRUITING
Lemont
Kansas
Retina Associates, LLC
RECRUITING
Lenexa
Kentucky
Butchertown Clinical Trials
RECRUITING
Louisville
Massachusetts
Retina Research Institute at New England Retina Consultants, PC
RECRUITING
Springfield
Maryland
Mid Atlantic Retina Specialists
RECRUITING
Hagerstown
Maine
Maine Eye Center (Site 097)
RECRUITING
Portland
Minnesota
Retina Consultants of Minnesota
RECRUITING
Edina
North Carolina
Asheville Eye Associates, Retina Division (Site 077)
RECRUITING
Asheville
NC Retina
RECRUITING
Cary
Graystone Eye
RECRUITING
Hickory
NC Retina Associates
RECRUITING
Wake Forest
New Jersey
Envision Ocular, LLC
RECRUITING
Bloomfield
New York
Long Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY
RECRUITING
Great Neck
Retina Associates of Western NY, PC (Site 051)
RECRUITING
Rochester
Oregon
Retina Consultants, LLC
RECRUITING
Salem
Cascade Medical Research Institute, LLC
RECRUITING
Springfield
Pennsylvania
Erie Retina Research
RECRUITING
Erie
South Carolina
Charleston Neuroscience Institute (Site 034)
RECRUITING
Beaufort
Palmetto Retina Center
RECRUITING
Florence
Charleston Neuroscience Institute
RECRUITING
Ladson
Palmetto Retina Center
RECRUITING
West Columbia
Tennessee
Southeastern Retina Associates
RECRUITING
Hixson
Southeastern Retina Associates (Site 095)
RECRUITING
Johnson City
Southeastern Retina Associates, P.C.
RECRUITING
Knoxville
Tennessee Retina
RECRUITING
Nashville
Texas
Retina Consultants of Texas
RECRUITING
Bellaire
Texas Retina Associates
RECRUITING
Fort Worth
Retina Consultants of Texas
RECRUITING
Katy
Austin Retina Associates
RECRUITING
Round Rock
Retina Consultants of Texas
RECRUITING
San Antonio
Austin Retina Associates
RECRUITING
San Marcos
Retina Consultants of Texas
RECRUITING
Schertz
Utah
Salt Lake Retina
RECRUITING
West Jordan
Virginia
Vistar Eye Center (Site 129)
RECRUITING
Roanoke
Washington
Pacific Northwest Retina
RECRUITING
Bellevue
Wisconsin
Northeast Wisconsin Retina Associates
RECRUITING
Appleton
Other Locations
Brazil
IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia (Site 332)
RECRUITING
São Paulo
Colombia
Clinica Oftalmologica del Caribe (COFCA)
RECRUITING
Barranquilla
Fundacion Oftalmologica Nacional
RECRUITING
Bogotá
Clínica Imbanaco S.A.S
RECRUITING
Cali
Clinica de Oftalmologia Sandiego
RECRUITING
Medellín
France
Hopital Intercommunal De Creteil
RECRUITING
Créteil
Centre d'Ophtalmologie Paradis-Monticelli
RECRUITING
Marseille
Centre Ophtalmologique Saint Exupéry
RECRUITING
Saint-cyr-sur-loire
Hungary
Budapest Retina Associates
RECRUITING
Budapest
Italy
Presidio Ospedaliero Universitario Santa Maria della Misericordia Clinica Oculistica - Padiglione 7 - Piano 3
RECRUITING
Udine
Portugal
AIBILI Azinhaga de Santa Comba
RECRUITING
Coimbra
Espaço Médico de Coimbra
RECRUITING
Coimbra
Spain
Hospital General de Catalunya
RECRUITING
Barcelona
Oftalvist
RECRUITING
Burjassot -(valencia)
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-04-15
Estimated Completion Date: 2028-07-31
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 8weeks (Q8W) until week 48. After week48, 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 week48. 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.