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 (9) 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
Northern California Retina Vitreous Associates Medical Group, Inc.
RECRUITING
Mountain View
Illinois
University Retina & Macula Associates, P.C.
RECRUITING
Lemont
Maryland
Mid Atlantic Retina Specialists
RECRUITING
Hagerstown
Minnesota
Retina Consultants of Minnesota
RECRUITING
Edina
New Jersey
Envision Ocular, LLC
RECRUITING
Bloomfield
Pennsylvania
Erie Retina Research
RECRUITING
Erie
South Carolina
Charleston Neuroscience Institute
RECRUITING
Ladson
Texas
Retina Consultants of Texas
RECRUITING
Bellaire
Washington
Pacific Northwest Retina
RECRUITING
Bellevue
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