Phase 3Recruiting
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
A Randomized, Double-Masked, Multicenter, 3-Arm, Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) MK-8748 Compared With Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
- Sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrolment
- 960 planned
- Conditions
- Diabetic Retinopathy; Macular Edema
- Interventions
- MK-8748; Aflibercept
- Ages
- adults, older adults
- Registry
- NCT07705555, CTIS2026-526790-42-00
Full record on ClinicalTrials.gov
From the registry
Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME. An available standard (usual) treatment for DME is aflibercept. However, standard treatments such as aflibercept may not work for every person. The main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.
Primary outcomes
- Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered