Compares a trial medicine, MK-8748, with aflibercept for diabetic macular edema
Tests MK-8748 against aflibercept in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Key facts
- Where
- Bristol, United KingdomSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 or type 2 diabetes whose vision has dropped mainly because of diabetic macular edema (swelling in the centre of the retina).
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Diabetic macular edema in the study eye, causing a decrease in vision. If never treated for it, the diagnosis must be within 9 months of screening. If treated before, the first treatment must be no longer than 3 years before screening.
- Earlier treatment
- People who never had treatment for diabetic macular edema must have been diagnosed within 9 months of screening. People who had treatment must have had their first treatment no longer than 3 years before screening.
- Biomarker or test result
- Hemoglobin A1c (HbA1c) of ≤12% (108 mmol/mol).
Main reasons for not taking part
- Kidney failure needing a kidney transplant or dialysis, or expected to need dialysis during the study
- Stroke or heart attack within 180 days before the first dose
- Newly diagnosed or untreated diabetes with diabetes medicine started within 3 months before the first dose
- Cataract or minimally invasive glaucoma surgery in the study eye within 90 days of screening
- Advanced or uncontrolled glaucoma, past retinal detachment, other active retinal disease in the study eye, or uncontrolled blood pressure
Read by machine on 13 November 2026.
Where in United Kingdom
- Bristol Eye Hospital (Site 0902)Bristol, United KingdomContact: Study CoordinatorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07705555EU 2026-526790-42-01
- Record updated
- 12 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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 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 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 history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening; 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; The main exclusion criteria include but are not limited to the following:; Has advanced or uncontrolled glaucoma in the study eye; Has uncontrolled blood pressure at screening.