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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07705555

Registry updated: 2026-10-20
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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. The main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.

Interventions

  • MK-8748 (Drug)
    Administered by intravitreal injection (IVT)
  • Aflibercept (Drug)
    Administered by intravitreal injection (IVT)

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

Conditions

Diabetic Retinopathy Macular Edema

Locations

  • Global Research Management ( Site 0066) — Glendale, California, United States
  • Retinal Consultants Medical Group ( Site 0013) — Sacramento, California, United States
  • Retina Specialists of Colorado ( Site 0068) — Denver, Colorado, United States
  • Retina Consultants ( Site 0065) — Manchester, Connecticut, United States
  • Vitreo Retinal Associates ( Site 0042) — Gainesville, Florida, United States
  • Retina Care Specialists ( Site 0095) — Palm Beach Gardens, Florida, United States
  • Retina Vitreous Associates of Florida ( Site 0034) — Tampa, Florida, United States
  • Retina Associates LLC ( Site 0024) — Lenexa, Kansas, United States
  • Mid Atlantic Retina ( Site 0062) — Hagerstown, Maryland, United States
  • Retina Specialists ( Site 0074) — Towson, Maryland, United States
  • Mississippi Retina Associates, P.A. ( Site 0061) — Madison, Mississippi, United States
  • Envision Ocular, LLC ( Site 0039) — Bloomfield, New Jersey, United States
  • Retina Associates of Western NY, PC ( Site 0038) — Rochester, New York, United States
  • North Carolina Retina Associates ( Site 0064) — Wake Forest, North Carolina, United States
  • Charleston Neuroscience Institute ( Site 0087) — Bluffton, South Carolina, United States
  • Palmetto Retina Center ( Site 0063) — Florence, South Carolina, United States
  • Palmetto Retina Center ( Site 0014) — West Columbia, South Carolina, United States
  • Southeastern Retina Associates PC ( Site 0071) — Johnson City, Tennessee, United States
  • Southeastern Retina Associates PC ( Site 0018) — Knoxville, Tennessee, United States
  • Austin Retina Associates ( Site 0008) — Austin, Texas, United States
  • Retina Consultants of Texas ( Site 0001) — Bellaire, Texas, United States
  • Austin Retina Associates ( Site 0080) — San Marcos, Texas, United States
  • Retina Consultants of Texas ( Site 0029) — Schertz, Texas, United States
  • Retina Consultants ( Site 0104) — Charleston, West Virginia, United States
  • Fundacion Zambrano ( Site 0402) — CABA, Argentina
  • Eyeclinic Albury-Wodonga ( Site 2204) — Albury, New South Wales, Australia
  • Sydney Retina Clinic and Day Surgery ( Site 2203) — Sydney, New South Wales, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record