A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
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)
2 other identifiers
interventional
960
2 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 15, 2026
CompletedStudy Start
First participant enrolled
August 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
October 1, 2026
September 1, 2026
2.2 years
July 10, 2026
September 30, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline and 1 Year
Secondary Outcomes (50)
Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52
Baseline and Week 52
Mean Change in CST from Baseline Over Time
Up to approximately 2 years
Time to Absence of Diabetic Macular Edema (DME) at Week 52
Up to approximately Week 52
Proportion of Participants with Absence of Intraretinal Fluid Over Time
Up to approximately 2 years
Proportion of Participants with Absence of Subretinal Fluid Over Time
Up to approximately 2 years
- +45 more secondary outcomes
Study Arms (3)
MK-8748 Low Dose
EXPERIMENTALParticipants receive 5 initial administrations of MK-8748 low dose every 4 weeks (Q4W), then continue to receive MK-8748 low dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100.
MK-8748 High Dose
EXPERIMENTALParticipants receive 5 initial administrations of MK-8748 high dose every 4 weeks (Q4W), then continue to receive MK-8748 high dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100.
Aflibercept 2 mg
ACTIVE COMPARATORParticipants receive 5 initial administrations of aflibercept 2 mg every 4 weeks (Q4W), then continue to receive aflibercept 2mg every 8 weeks (Q8W) until week 100.
Interventions
Administered by intravitreal injection (IVT)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Global Research Management ( Site 0066)
Glendale, California, 91204, United States
Retinal Consultants Medical Group ( Site 0013)
Sacramento, California, 95825, United States
Retina Specialists of Colorado ( Site 0068)
Denver, Colorado, 80222, United States
Retina Vitreous Associates of Florida ( Site 0034)
Tampa, Florida, 33617, United States
Mid Atlantic Retina ( Site 0062)
Hagerstown, Maryland, 21740, United States
Envision Ocular, LLC ( Site 0039)
Bloomfield, New Jersey, 07003, United States
Retina Associates of Western NY, PC ( Site 0038)
Rochester, New York, 14620, United States
North Carolina Retina Associates ( Site 0064)
Wake Forest, North Carolina, 27587, United States
Charleston Neuroscience Institute ( Site 0087)
Bluffton, South Carolina, 29910, United States
Palmetto Retina Center ( Site 0063)
Florence, South Carolina, 29501, United States
Palmetto Retina Center ( Site 0014)
West Columbia, South Carolina, 29169, United States
Southeastern Retina Associates PC ( Site 0071)
Johnson City, Tennessee, 37604, United States
Southeastern Retina Associates PC ( Site 0018)
Knoxville, Tennessee, 37922-3572, United States
Austin Retina Associates ( Site 0008)
Austin, Texas, 78705, United States
Retina Consultants of Texas ( Site 0001)
Bellaire, Texas, 77401, United States
Retina Consultants of Texas ( Site 0029)
Schertz, Texas, 78154, United States
Retina Consultants ( Site 0104)
Charleston, West Virginia, 25301, United States
Eyeclinic Albury-Wodonga ( Site 2204)
Albury, New South Wales, 2640, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2026
First Posted
July 15, 2026
Study Start
August 27, 2026
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2029
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf