What this study is
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.
What's being tested
- MK-8748
Intervention · DRUG
- Aflibercept
Intervention · DRUG
Both interventions
Administered by intravitreal injection (IVT)
Study details
- 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)
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Diabetic Retinopathy · Macular Edema
- Enrolling
- 1,104 people
- Starts
- 2026-09-25
- Est. completion
- 2029-11-30
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (20)
20 openSouth Coast Retina Center ( Site 0121)
Long Beach, California, United States
- Study Coordinator · Contact562-984-7024
RecruitingRetina Group of New England ( Site 0101)
Waterford, Connecticut, United States
- Study Coordinator · Contact860-444-1292
RecruitingFlorida Retina Institute ( Site 0035)
Orlando, Florida, United States
- Study Coordinator · Contact407-849-9621
RecruitingRetina Vitreous Associates of Florida ( Site 0036)
St. Petersburg, Florida, United States
- Study Coordinator · Contact727-323-0077
RecruitingCenter for Retina and Macular Disease ( Site 0047)
Winter Haven, Florida, United States
- Study Coordinator · Contact863-297-5400
RecruitingAssociated Vitreoretinal and Uveitis Consultants ( Site 0099)
Carmel, Indiana, United States
- Study Coordinator · Contact317-571-1501
RecruitingWolfe Eye Clinic ( Site 0044)
West Des Moines, Iowa, United States
- Study Coordinator · Contact515-223-8685
RecruitingCumberland Valley Retina Consultants ( Site 0003)
Hagerstown, Maryland, United States
- Study Coordinator · Contact301-665-1712
RecruitingRetina-Vitreous Surgeons of Central NY ( Site 0021)
Liverpool, New York, United States
- Study Coordinator · Contact315-445-8166
RecruitingNorth Carolina Retina Associates ( Site 0122)
Greenville, North Carolina, United States
- Study Coordinator · Contact919-782-8091
RecruitingGraystone Eye ( Site 0059)
Hickory, North Carolina, United States
- Study Coordinator · Contact828-304-6643
RecruitingPiedmont Retina Specialists ( Site 0049)
Winston-Salem, North Carolina, United States
- Study Coordinator · Contact336-397-9216
RecruitingPalmetto Retina Center ( Site 0073)
Aiken, South Carolina, United States
- Study Coordinator · Contact803-931-0077
RecruitingCharleston Neuroscience Institute ( Site 0090)
Beaufort, South Carolina, United States
- Study Coordinator · Contact843-763-4466
RecruitingCharleston Neuroscience Institute ( Site 0076)
Charleston, South Carolina, United States
- Study Coordinator · Contact843-763-4466
RecruitingRetina Consultants of South Carolina ( Site 0026)
Ladson, South Carolina, United States
- Study Coordinator · Contact843-763-4466
Recruiting- Recruiting
Texas Retina Associates ( Site 0055)
Fort Worth, Texas, United States
- Study Coordinator · Contact817-334-0882
RecruitingRetina Consultants of Texas - Katy/Cinco Ranch ( Site 0100)
Katy, Texas, United States
- Study Coordinator · Contact713-524-3434
RecruitingRetina Center of Texas ( Site 0096)
Southlake, Texas, United States
- Study Coordinator · Contact817-865-6800
Recruiting
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 8748-005
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.