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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Sponsor: Merck Sharp & Dohme LLC
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
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
MK-8748
Administered by intravitreal injection (IVT)
Aflibercept
Administered by intravitreal injection (IVT)
Locations (35)
Associated Retina Consultants, Ltd ( Site 0084)
Gilbert, Arizona, United States
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 Care Specialists ( Site 0095)
Palm Beach Gardens, Florida, United States
Retina Vitreous Associates of Florida ( Site 0034)
Tampa, Florida, United States
Florida Retina Institute ( Site 0105)
Wildwood, Florida, United States
Midwest Eye Institute ( Site 0113)
Carmel, Indiana, United States
Retina Associates LLC ( Site 0024)
Lenexa, Kansas, United States
Mid Atlantic Retina ( Site 0062)
Hagerstown, Maryland, United States
Retina Specialists ( Site 0074)
Towson, Maryland, United States
Mississippi Retina Associates, P.A. ( Site 0061)
Madison, Mississippi, United States
Envision Ocular, LLC ( Site 0039)
Bloomfield, New Jersey, United States
Mid Atlantic Retina ( Site 0048)
Cherry Hill, 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
Charleston Neuroscience Institute ( Site 0022)
Mt. Pleasant, 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
Austin Retina Associates ( Site 0080)
San Marcos, Texas, United States
Retina Consultants of Texas ( Site 0029)
Schertz, Texas, United States
Retina Consultants ( Site 0104)
Charleston, West Virginia, United States
Fundacion Zambrano ( Site 0402)
CABA, Argentina
Eyeclinic Albury-Wodonga ( Site 2204)
Albury, New South Wales, Australia
Marsden Eye Specialists ( Site 2200)
Parramatta, New South Wales, Australia
Strathfield Retina Clinic ( Site 2202)
Strathfield, New South Wales, Australia
Sydney Retina Clinic and Day Surgery ( Site 2203)
Sydney, New South Wales, Australia
Bristol Eye Hospital ( Site 0902)
Bristol, Bristol, City of, United Kingdom