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)
EyeBiotech Ltd.
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
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
The main inclusion criteria include but are not limited to the following: * 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 The main exclusion criteria include but are not limited to the following * Has uncont…
Interventions
- DrugTiespectus
Administered by intravitreal (IVT) injection
- DrugAflibercept
Administered by intravitreal injection (IVT)
Locations (30)
- Retina Partners of Northwest Arkansas, PLLCSpringdale, Arkansas
- Global Research Management, Inc.Glendale, California
- Retinal Consultants Medical Group (Site 024)Modesto, California
- Retina Consultants of Southern California (Site 043)Redlands, California
- Retinal Consultants Medical Group (Site 020)Sacramento, California
- Retinal Consultants Medical Group (Site 022)Sacramento, California