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

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: 960 · Started: Aug 27, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07705555

Locations in the U.S.

ArizonaAssociated Retina Consultants, Ltd ( Site 0084), Gilbert
CaliforniaGlobal Research Management ( Site 0066), Glendale
Retinal Consultants Medical Group ( Site 0013), Sacramento
ColoradoRetina Specialists of Colorado ( Site 0068), Denver
ConnecticutRetina Consultants ( Site 0065), Manchester
FloridaVitreo Retinal Associates ( Site 0042), Gainesville
Retina Care Specialists ( Site 0095), Palm Beach Gardens
Retina Vitreous Associates of Florida ( Site 0034), Tampa
Florida Retina Institute ( Site 0105), Wildwood
IndianaMidwest Eye Institute ( Site 0113), Carmel
KansasRetina Associates LLC ( Site 0024), Lenexa
MarylandMid Atlantic Retina ( Site 0062), Hagerstown
Retina Specialists ( Site 0074), Towson
MassachusettsNew England Retina Consultants ( Site 0020), Springfield
MississippiMississippi Retina Associates, P.A. ( Site 0061), Madison
New JerseyEnvision Ocular, LLC ( Site 0039), Bloomfield
Mid Atlantic Retina ( Site 0048), Cherry Hill
New YorkRetina Associates of Western NY, PC ( Site 0038), Rochester
North CarolinaAsheville Eye Associates ( Site 0058), Asheville
North Carolina Retina Associates ( Site 0064), Wake Forest
OhioCincinnati Eye Institute ( Site 0108), Cincinnati
South CarolinaCharleston Neuroscience Institute ( Site 0087), Bluffton
Palmetto Retina Center ( Site 0063), Florence
Charleston Neuroscience Institute ( Site 0022), Mt. Pleasant
Palmetto Retina Center ( Site 0014), West Columbia
TennesseeSoutheastern Retina Associates PC ( Site 0072), Hixson
Southeastern Retina Associates PC ( Site 0071), Johnson City
Southeastern Retina Associates PC ( Site 0018), Knoxville
TexasAustin Research Center for Retina ( Site 0033), Austin
Austin Retina Associates ( Site 0008), Austin
Retina Consultants of Texas ( Site 0001), Bellaire
Texas Retina Associates ( Site 0025), Plano
Austin Retina Associates ( Site 0080), San Marcos
Retina Consultants of Texas ( Site 0029), Schertz
Retina Consultants of Texas ( Site 0010), The Woodlands
VirginiaPiedmont Eye Center, Inc. ( Site 0041), Lynchburg
West VirginiaRetina Consultants ( Site 0104), Charleston

Conditions

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