Recruiting
Phase 3

MK-8748 vs. Aflibercept

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07705555

Conditions

Diabetic Retinopathy

Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-8748

Aflibercept

Study Details

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.

Conditions

Diabetic Retinopathy

Macular Edema

Study ID

NCT07705555

Start date

Aug 27, 2026

Status verified date

Aug, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MK-8748

Administered by intravitreal injection (IVT)

Aflibercept

Administered by intravitreal injection (IVT)

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 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Global Research Management

Recruiting

Glendale, California, United States, 91204

Contacts

Study Coordinator

818-246-2560

Retina Associates of Western NY, PC

Recruiting

Rochester, New York, United States, 14620

Contacts

Study Coordinator

585-450-2082

Southeastern Retina Associates PC

Recruiting

Johnson City, Tennessee, United States, 37604

Contacts

Study Coordinator

423-578-4364

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Diabetic Macular Edema (DME)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-02.