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

NCT07705555 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 8748-004MK-8748-004
• Study Type: interventional
• Target: 960
• Locations: 0 countries
• Sites: N/A

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

Keywords

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1

  Participants' BCVA in the study eye will be measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to Year 1 will be assessed.

  Baseline and 1 Year

Secondary Outcomes (50)

• Mean Change in Central Subfield Thickness (CST) from Baseline to Week 52

  Baseline and Week 52

• Mean Change in CST from Baseline Over Time

  Up to approximately 2 years

• Time to Absence of Diabetic Macular Edema (DME) at Week 52

  Up to approximately Week 52

• Proportion of Participants with Absence of Intraretinal Fluid Over Time

  Up to approximately 2 years

• Proportion of Participants with Absence of Subretinal Fluid Over Time

  Up to approximately 2 years

Study Arms (3)

MK-8748 Low Dose

EXPERIMENTAL

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

MK-8748 High Dose

EXPERIMENTAL

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

Aflibercept 2 mg

ACTIVE COMPARATOR

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

Interventions

MK-8748 DRUG

Administered by intravitreal injection (IVT)

Also known as: EYE201, Tiespectus

MK-8748 High Dose; MK-8748 Low Dose

Aflibercept DRUG

Administered by intravitreal injection (IVT)

Also known as: Eylea

Aflibercept 2 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share