A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MK-8748
DrugAdministered by intravitreal injection (IVT)
Aflibercept
DrugAdministered by intravitreal injection (IVT)
Treatment groups
1,104 Participants
are divided into 3 treatment groupsGroup A: MK-8748 Low DoseExperimental treatment 1 intervention
Group B: MK-8748 High DoseExperimental treatment 1 intervention
Group C: Aflibercept 2 mgActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1
Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to Year 1 will be assessed.
Time frame
Baseline and 1 YearSecondary outcomes
1
Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
Central subfield thickness (CST) in the study eye will be measured in microns using optical coherence tomography (OCT). The mean change in CST from baseline to Year 1 will be presented.
Time frame
Baseline and Week 522
Mean Change in CST from Baseline Over Time
Central subfield thickness (CST) in the study eye will be measured in microns using optical coherence tomography (OCT). The mean change in CST from baseline over time will be presented.
Time frame
Up to approximately 2 years3
Time to Absence of Diabetic Macular Edema (DME) at Week 52
The absence of Diabetic Macular Edema (DME) is defined as a Central Subfield Thickness (CST) of \<300 μm measured using optical coherence tomography (OCT). The time to absence of Diabetic Macular Edema (DME) in the study eye up to Week 52 will be presented.
Time frame
Up to approximately Week 524
Proportion of Participants with Absence of Intraretinal Fluid Over Time
Participants' intraretinal fluid in the study eye will be measured using optical coherence tomography (OCT). The proportion of participants with absence of intraretinal fluid over time will be presented.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov