Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You
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 (20) 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
California
Retinal Consultants Medical Group
RECRUITING
Modesto
Retina Consultants of Southern California
RECRUITING
Redlands
Retinal Consultants Medical Group
RECRUITING
Sacramento
Retinal Consultants Medical Group
RECRUITING
Sacramento
Florida
Retina Group of Florida
RECRUITING
Fort Lauderdale
Fort Lauderdale Eye Institute
RECRUITING
Plantation
Retina Vitreous Associates of Florida
RECRUITING
St. Petersburg
Maryland
Cumberland Valley Retina Consultants
RECRUITING
Hagerstown
Michigan
Foundation for Vision Research
RECRUITING
Grand Rapids
Mississippi
Mississippi Retina Associates
RECRUITING
Madison
New York
ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY
RECRUITING
Hauppauge
Retina Vitreous Surgeons of CNY, PC
RECRUITING
Liverpool
South Carolina
Charleston Neuroscience Institute - Bluffton
RECRUITING
Bluffton
Charleston Neuroscience Institute
RECRUITING
Charleston
Texas
Retina Research Institute of Texas
RECRUITING
Abilene
Austin Retina Associates
RECRUITING
Austin
Texas Retina
RECRUITING
Plano
Retina Consultants of Texas
RECRUITING
The Woodlands
Virginia
Piedmont Eye Center
RECRUITING
Lynchburg
Washington
Pacific Northwest Retina
RECRUITING
Burlington
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