Recruiting
Phase 3

MK-8748 vs. Aflibercept

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07705607

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

NCT07705607

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 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

1104 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@merck.com

Locations

Charleston Neuroscience Institute ( Site 0076)

Recruiting

Charleston, South Carolina, United States, 29414

Contacts

Study Coordinator

843-763-4466

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • Diabetic Macular Edema (DME)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.