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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%
* Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)
* For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or has renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study
* Has history of stroke (cerebral vascular accident) or myocardial infarction within 180 days to first dose of study intervention
* Has newly diagnosed or previously untreated diabetes mellitus and initiated oral or injectable anti-diabetic medication within 3 months to first dose of study intervention
* Has history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening
* Has any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy in the study eye within 90 days of screening
* Has advanced or uncontrolled glaucoma in the study eye
* Has any history of retinal detachment or treatment or surgery for retinal detachment in the study eye
* Has active retinal disease other than the condition under investigation in the study eye
* Has uncontrolled blood pressure at screening

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,104 · Started: Sep 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07705607

Locations in the U.S.

ArizonaAssociated Retina Consultants, Ltd ( Site 0082), Phoenix
CaliforniaCalifornia Retina Consultants ( Site 0023), Bakersfield
Retina-Vitreous Associates Medical Group ( Site 0124), Beverly Hills
South Coast Retina Center ( Site 0121), Long Beach
Retinal Consultants Medical Group ( Site 0017), Modesto
Retinal Consultants Medical Group ( Site 0015), Sacramento
ConnecticutRetina Group of New England ( Site 0101), Waterford
FloridaFlorida Retina Institute ( Site 0035), Orlando
Retina Vitreous Associates of Florida ( Site 0036), St. Petersburg
Center for Retina and Macular Disease ( Site 0047), Winter Haven
IndianaAssociated Vitreoretinal and Uveitis Consultants ( Site 0099), Carmel
IowaWolfe Eye Clinic ( Site 0044), West Des Moines
MarylandCumberland Valley Retina Consultants ( Site 0003), Hagerstown
New YorkRetina-Vitreous Surgeons of Central NY ( Site 0021), Liverpool
North CarolinaNorth Carolina Retina Associates ( Site 0122), Greenville
Graystone Eye ( Site 0059), Hickory
Piedmont Retina Specialists ( Site 0049), Winston-Salem
South CarolinaPalmetto Retina Center ( Site 0073), Aiken
Charleston Neuroscience Institute ( Site 0090), Beaufort
Charleston Neuroscience Institute ( Site 0076), Charleston
Retina Consultants of South Carolina ( Site 0026), Ladson
TexasTexas Retina ( Site 0051), Arlington
Texas Retina Associates ( Site 0055), Fort Worth
Retina Consultants of Texas - Katy/Cinco Ranch ( Site 0100), Katy
Retina Consultants of Texas ( Site 0005), San Antonio
Retina Center of Texas ( Site 0096), Southlake

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.