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RECRUITING
NCT07705555
PHASE3

A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

960

Start Date

2026-08-27

Completion Date

2029-10-31

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

MK-8748

Administered by intravitreal injection (IVT)

DRUG

Aflibercept

Administered by intravitreal injection (IVT)

Locations (23)

Global Research Management ( Site 0066)

Glendale, California, United States

Retinal Consultants Medical Group ( Site 0013)

Sacramento, California, United States

Retina Specialists of Colorado ( Site 0068)

Denver, Colorado, United States

Retina Consultants ( Site 0065)

Manchester, Connecticut, United States

Vitreo Retinal Associates ( Site 0042)

Gainesville, Florida, United States

Retina Vitreous Associates of Florida ( Site 0034)

Tampa, Florida, United States

Retina Associates LLC ( Site 0024)

Lenexa, Kansas, United States

Mid Atlantic Retina ( Site 0062)

Hagerstown, Maryland, United States

Mississippi Retina Associates, P.A. ( Site 0061)

Madison, Mississippi, United States

Envision Ocular, LLC ( Site 0039)

Bloomfield, New Jersey, United States

Retina Associates of Western NY, PC ( Site 0038)

Rochester, New York, United States

North Carolina Retina Associates ( Site 0064)

Wake Forest, North Carolina, United States

Charleston Neuroscience Institute ( Site 0087)

Bluffton, South Carolina, United States

Palmetto Retina Center ( Site 0063)

Florence, South Carolina, United States

Palmetto Retina Center ( Site 0014)

West Columbia, South Carolina, United States

Southeastern Retina Associates PC ( Site 0071)

Johnson City, Tennessee, United States

Southeastern Retina Associates PC ( Site 0018)

Knoxville, Tennessee, United States

Austin Retina Associates ( Site 0008)

Austin, Texas, United States

Retina Consultants of Texas ( Site 0001)

Bellaire, Texas, United States

Retina Consultants of Texas ( Site 0029)

Schertz, Texas, United States

Retina Consultants ( Site 0104)

Charleston, West Virginia, United States

Eyeclinic Albury-Wodonga ( Site 2204)

Albury, New South Wales, Australia

Sydney Retina Clinic and Day Surgery ( Site 2203)

Sydney, New South Wales, Australia