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NCT07705555From ClinicalTrials.govRecruiting

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

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)

  • Diabetic Retinopathy
  • Macular Edema

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
960
Started
27 August 2026
Main results due
31 October 2028
Study sites
12
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(12)

  • Global Research Management ( Site 0066)

    Glendale, California, United States

    Recruiting

  • Retina Specialists of Colorado ( Site 0068)

    Denver, Colorado, United States

    Recruiting

  • Retina Vitreous Associates of Florida ( Site 0034)

    Tampa, Florida, United States

    Recruiting

  • Mid Atlantic Retina ( Site 0062)

    Hagerstown, Maryland, United States

    Recruiting

  • Envision Ocular, LLC ( Site 0039)

    Bloomfield, New Jersey, United States

    Recruiting

  • Retina Associates of Western NY, PC ( Site 0038)

    Rochester, New York, United States

    Recruiting

  • Palmetto Retina Center ( Site 0063)

    Florence, South Carolina, United States

    Recruiting

  • Palmetto Retina Center ( Site 0014)

    West Columbia, South Carolina, United States

    Recruiting

  • Southeastern Retina Associates PC ( Site 0071)

    Johnson City, Tennessee, United States

    Recruiting

  • Austin Retina Associates ( Site 0008)

    Austin, Texas, United States

    Recruiting

  • Retina Consultants of Texas ( Site 0001)

    Bellaire, Texas, United States

    Recruiting

  • Eyeclinic Albury-Wodonga ( Site 2204)

    Albury, New South Wales, Australia

    Recruiting

Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07705555. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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