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

RecruitingPhase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค12% * 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-naรฏve 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
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What it tests

  • MK-8748
  • Aflibercept
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Where

33 sites
Associated Retina Consultants, Ltd ( Site 0084)
Gilbert, United States
Global Research Management ( Site 0066)
Glendale, United States
Retinal Consultants Medical Group ( Site 0013)
Sacramento, United States
Retina Specialists of Colorado ( Site 0068)
Denver, United States
Retina Consultants ( Site 0065)
Manchester, United States
Vitreo Retinal Associates ( Site 0042)
Gainesville, United States
Retina Care Specialists ( Site 0095)
Palm Beach Gardens, United States
Retina Vitreous Associates of Florida ( Site 0034)
Tampa, United States

โ€ฆand 25 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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