A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07705555
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-8748 — DRUG
    Administered by intravitreal injection (IVT)
  • Aflibercept — DRUG
    Administered by intravitreal injection (IVT)

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 28, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
960 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 ]

Find similar trials

Nationwide
Diabetic retinopathy trialsOphthalmology trialsRetina trials

Related Studies