Recruiting

Phase 3

MK-8748 vs. AfliberceptA Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)

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 25, 2026

Status verified date

Nov, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

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

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

Locations

Associated Retina Consultants, Ltd ( Site 0082)

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

Study Coordinator

480-999-5458

California Retina Consultants ( Site 0023)

Recruiting

Bakersfield, California, United States, 93309

Contacts

Study Coordinator

661-325-4593

Retina-Vitreous Associates Medical Group ( Site 0124)

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Study Coordinator

310-289-2478

South Coast Retina Center ( Site 0121)

Recruiting

Long Beach, California, United States, 90807

Contacts

Study Coordinator

562-984-7024

Retinal Consultants Medical Group ( Site 0017)

Recruiting

Modesto, California, United States, 95356

Contacts

Study Coordinator

209-898-0073

Retinal Consultants Medical Group ( Site 0015)

Recruiting

Sacramento, California, United States, 95841

Contacts

Study Coordinator

847-773-4563

Retina Group of New England ( Site 0101)

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Study Coordinator

860-444-1292

Florida Retina Institute ( Site 0035)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

407-849-9621

Retina Vitreous Associates of Florida ( Site 0036)

Recruiting

St. Petersburg, Florida, United States, 33711

Contacts

Study Coordinator

727-323-0077

Center for Retina and Macular Disease ( Site 0047)

Recruiting

Winter Haven, Florida, United States, 33880

Contacts

Study Coordinator

863-297-5400

Associated Vitreoretinal and Uveitis Consultants ( Site 0099)

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Study Coordinator

317-571-1501

Wolfe Eye Clinic ( Site 0044)

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Study Coordinator

515-223-8685

Cumberland Valley Retina Consultants ( Site 0003)

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Study Coordinator

301-665-1712

Retina-Vitreous Surgeons of Central NY ( Site 0021)

Recruiting

Liverpool, New York, United States, 13088

Contacts

Study Coordinator

315-445-8166

North Carolina Retina Associates ( Site 0122)

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Study Coordinator

919-782-8091

Graystone Eye ( Site 0059)

Recruiting

Hickory, North Carolina, United States, 28602

Contacts

Study Coordinator

828-304-6643

Piedmont Retina Specialists ( Site 0049)

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Study Coordinator

336-397-9216

Palmetto Retina Center ( Site 0073)

Recruiting

Aiken, South Carolina, United States, 29801

Contacts

Study Coordinator

803-931-0077

Charleston Neuroscience Institute ( Site 0090)

Recruiting

Beaufort, South Carolina, United States, 29902

Contacts

Study Coordinator

843-763-4466

Charleston Neuroscience Institute ( Site 0076)

Recruiting

Charleston, South Carolina, United States, 29414

Contacts

Study Coordinator

843-763-4466

Retina Consultants of South Carolina ( Site 0026)

Recruiting

Ladson, South Carolina, United States, 29456

Contacts

Study Coordinator

843-763-4466

Texas Retina ( Site 0051)

Recruiting

Arlington, Texas, United States, 76012

Contacts

Study Coordinator

817-261-9625

Texas Retina Associates ( Site 0055)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-334-0882

Retina Consultants of Texas - Katy/Cinco Ranch ( Site 0100)

Recruiting

Katy, Texas, United States, 77494

Contacts

Study Coordinator

713-524-3434

Retina Consultants of Texas ( Site 0005)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-903-1046

Retina Center of Texas ( Site 0096)

Recruiting

Southlake, Texas, United States, 76092

Contacts

Study Coordinator

817-865-6800

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

Diabetic Macular Edema (DME)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.