Last updated 2 days ago
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
960 patients around the world
Available in Argentina, United States
Merck Sharp & Dohme LLC
1Research sites
960Patients around the world
This study is for people with
Diabetic retinopathy
Diabetic macular edema
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Fundación Zambrano
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Diabetic macular edema
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07705555
