Phase 2/3RecruitingAge-related condition

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) (MALBEC)

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)

Sponsor
EyeBiotech Ltd. (Industry)
Enrolment
960 planned
Conditions
Macular Degeneration; Age-Related Macular Degeneration; Choroidal Neovascularization; Wet Macular Degeneration
Interventions
Tiespectus; Aflibercept
Ages
adults, older adults
Registry
NCT07440225

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Mean Change in Best-Corrected Visual Acuity (BCVA) [Early Treatment of Diabetic Retinopathy Study (ETDRS Letters)] From Baseline to Year 1

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered