Recruiting

Phase 3

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

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

Oct, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 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

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

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

Locations

Global Research Management ( Site 0066)

Recruiting

Glendale, California, United States, 91204

Contacts

Study Coordinator

818-246-2560

Retinal Consultants Medical Group ( Site 0013)

Recruiting

Sacramento, California, United States, 95825

Contacts

Study Coordinator

916-974-9279

Retina Specialists of Colorado ( Site 0068)

Recruiting

Denver, Colorado, United States, 80222

Contacts

Study Coordinator

720-443-2425

Retina Consultants ( Site 0065)

Recruiting

Manchester, Connecticut, United States, 06042

Contacts

Study Coordinator

860-646-7704

Vitreo Retinal Associates ( Site 0042)

Recruiting

Gainesville, Florida, United States, 32607

Contacts

Study Coordinator

352-519-5621

Retina Care Specialists ( Site 0095)

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

Study Coordinator

561-624-0099

Retina Vitreous Associates of Florida ( Site 0034)

Recruiting

Tampa, Florida, United States, 33617

Contacts

Study Coordinator

813-987-2000

Retina Associates LLC ( Site 0024)

Recruiting

Lenexa, Kansas, United States, 66215

Contacts

Study Coordinator

913-831-7400

Mid Atlantic Retina ( Site 0062)

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Study Coordinator

301-671-2400

Retina Specialists ( Site 0074)

Recruiting

Towson, Maryland, United States, 21204

Contacts

Study Coordinator

410-296-9748

Mississippi Retina Associates, P.A. ( Site 0061)

Recruiting

Madison, Mississippi, United States, 39110

Contacts

Study Coordinator

601-981-4091

Envision Ocular, LLC ( Site 0039)

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Study Coordinator

973-707-5632

Retina Associates of Western NY, PC ( Site 0038)

Recruiting

Rochester, New York, United States, 14620

Contacts

Study Coordinator

585-442-3411

North Carolina Retina Associates ( Site 0064)

Recruiting

Wake Forest, North Carolina, United States, 27587

Contacts

Study Coordinator

919-782-8038

Charleston Neuroscience Institute ( Site 0087)

Recruiting

Bluffton, South Carolina, United States, 29910

Contacts

Study Coordinator

843-763-4466

Palmetto Retina Center ( Site 0063)

Recruiting

Florence, South Carolina, United States, 29501

Contacts

Study Coordinator

803-931-0077

Palmetto Retina Center ( Site 0014)

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Study Coordinator

8039310077x124

Southeastern Retina Associates PC ( Site 0071)

Recruiting

Johnson City, Tennessee, United States, 37604

Contacts

Study Coordinator

423-578-4364

Southeastern Retina Associates PC ( Site 0018)

Recruiting

Knoxville, Tennessee, United States, 37922-3572

Contacts

Study Coordinator

865-934-3866

Austin Retina Associates ( Site 0008)

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

512-451-0103

Retina Consultants of Texas ( Site 0001)

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Study Coordinator

713-524-3434

Austin Retina Associates ( Site 0080)

Recruiting

San Marcos, Texas, United States, 78666

Contacts

Study Coordinator

512-451-0103

Retina Consultants of Texas ( Site 0029)

Recruiting

Schertz, Texas, United States, 78154

Contacts

Study Coordinator

210-693-1063

Retina Consultants ( Site 0104)

Recruiting

Charleston, West Virginia, United States, 25301

Contacts

Study Coordinator

304-346-4400

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

Diabetic Macular Edema (DME)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.