NCT07705555 A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
| NCT ID | NCT07705555 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Diabetic Retinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 960 participants |
| Start Date | 2026-08-27 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 960 participants in total. It began in 2026-08-27 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07705555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07705555 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 960 participants.
Is NCT07705555 currently recruiting?
Yes, NCT07705555 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07705555 trial being conducted?
This trial is being conducted at Glendale, United States, Rochester, United States, Johnson City, United States.
Who is sponsoring the NCT07705555 clinical trial?
NCT07705555 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 960 participants.