Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-8748 Low Dose
Participants 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.
  • Drug: MK-8748
    Administered by intravitreal injection (IVT)
    Other names:
    • EYE201
    • Tiespectus
Experimental
MK-8748 High Dose
Participants 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.
  • Drug: MK-8748
    Administered by intravitreal injection (IVT)
    Other names:
    • EYE201
    • Tiespectus
Active Comparator
Aflibercept 2 mg
Participants 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.
  • Drug: Aflibercept
    Administered by intravitreal injection (IVT)
    Other names:
    • Eylea

Recruiting Locations

Global Research Management ( Site 0066)
Glendale, California 91204
Contact:
Study Coordinator
818-246-2560

Retina Specialists of Colorado ( Site 0068)
Denver, Colorado 80222
Contact:
Study Coordinator
720-443-2425

Mid Atlantic Retina ( Site 0062)
Hagerstown, Maryland 21740
Contact:
Study Coordinator
301-671-2400

Envision Ocular, LLC ( Site 0039)
Bloomfield, New Jersey 07003
Contact:
Study Coordinator
973-707-5632

Retina Associates of Western NY, PC ( Site 0038)
Rochester, New York 14620
Contact:
Study Coordinator
585-442-3411

Southeastern Retina Associates PC ( Site 0071)
Johnson City, Tennessee 37604
Contact:
Study Coordinator
423-578-4364

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.