A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MK-8748, Aflibercept.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy, Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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
- Drug MK-8748
Administered by intravitreal injection (IVT) - Drug Aflibercept
Administered by intravitreal injection (IVT)
Primary outcome measures
- Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1 [Time frame: Baseline and 1 Year]
Secondary outcome measures (12)
- Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52 [Time frame: Baseline and Week 52]
- Mean Change in CST from Baseline Over Time [Time frame: Up to approximately 2 years]
- Time to Absence of Diabetic Macular Edema (DME) at Week 52 [Time frame: Up to approximately Week 52]
- Proportion of Participants with Absence of Intraretinal Fluid Over Time [Time frame: Up to approximately 2 years]
- Proportion of Participants with Absence of Subretinal Fluid Over Time [Time frame: Up to approximately 2 years]
- Proportion of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [Time frame: Up to approximately 2 years]
- Proportion of Participants with Diabetic Retinopathy Severity Scale (DRSS) Score Improvement of ≥2 Steps from Baseline to Year 1 [Time frame: Baseline and 1 Year]
- Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Year 1 [Time frame: Baseline and 1 Year]
- Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24 [Time frame: Up to approximately Week 24]
- Mean change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) from Baseline to Week 104 [Time frame: Baseline and Week 104]
- Proportion of Participants with DRSS Score Improvement of ≥2 Steps from Baseline to Week 104 [Time frame: Baseline and Week 104]
- Proportion of Participants with DRSS Score Improvement of ≥3 Steps from Baseline to Week 104 [Time frame: Baseline and Week 104]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07705607 · 8748-005 · MK-8748-005