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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.

CaliforniaGlobal Research Management ( Site 0066), Glendale
ColoradoRetina Specialists of Colorado ( Site 0068), Denver
FloridaRetina Vitreous Associates of Florida ( Site 0034), Tampa
MarylandMid Atlantic Retina ( Site 0062), Hagerstown
New JerseyEnvision Ocular, LLC ( Site 0039), Bloomfield
New YorkRetina Associates of Western NY, PC ( Site 0038), Rochester
South CarolinaPalmetto Retina Center ( Site 0063), Florence
Palmetto Retina Center ( Site 0014), West Columbia
TennesseeSoutheastern Retina Associates PC ( Site 0071), Johnson City
TexasAustin Retina Associates ( Site 0008), Austin
Retina Consultants of Texas ( Site 0001), Bellaire

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.