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Recruiting Phase 3

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

NCT07705555 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-08-27
Last updated
2026-10-23

Condition(s) studied

Diabetic RetinopathyMacular Edema

Investigational drug(s) / intervention(s)

MK-8748 →Aflibercept →

MK-8748: Administered by intravitreal injection (IVT)

Aflibercept: Administered by intravitreal injection (IVT)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (33)

FacilityCityRegionStatus
Associated Retina Consultants, Ltd ( Site 0084) Gilbert Arizona Recruiting
Global Research Management ( Site 0066) Glendale California Recruiting
Retinal Consultants Medical Group ( Site 0013) Sacramento California Recruiting
Retina Specialists of Colorado ( Site 0068) Denver Colorado Recruiting
Retina Consultants ( Site 0065) Manchester Connecticut Recruiting
Vitreo Retinal Associates ( Site 0042) Gainesville Florida Recruiting
Retina Care Specialists ( Site 0095) Palm Beach Gardens Florida Recruiting
Retina Vitreous Associates of Florida ( Site 0034) Tampa Florida Recruiting
Florida Retina Institute ( Site 0105) Wildwood Florida Recruiting
Midwest Eye Institute ( Site 0113) Carmel Indiana Recruiting
Retina Associates LLC ( Site 0024) Lenexa Kansas Recruiting
Mid Atlantic Retina ( Site 0062) Hagerstown Maryland Recruiting
Retina Specialists ( Site 0074) Towson Maryland Recruiting
Mississippi Retina Associates, P.A. ( Site 0061) Madison Mississippi Recruiting
Envision Ocular, LLC ( Site 0039) Bloomfield New Jersey Recruiting
Retina Associates of Western NY, PC ( Site 0038) Rochester New York Recruiting
North Carolina Retina Associates ( Site 0064) Wake Forest North Carolina Recruiting
Charleston Neuroscience Institute ( Site 0087) Bluffton South Carolina Recruiting
Palmetto Retina Center ( Site 0063) Florence South Carolina Recruiting
Charleston Neuroscience Institute ( Site 0022) Mt. Pleasant South Carolina Recruiting
Palmetto Retina Center ( Site 0014) West Columbia South Carolina Recruiting
Southeastern Retina Associates PC ( Site 0071) Johnson City Tennessee Recruiting
Southeastern Retina Associates PC ( Site 0018) Knoxville Tennessee Recruiting
Austin Retina Associates ( Site 0008) Austin Texas Recruiting
Retina Consultants of Texas ( Site 0001) Bellaire Texas Recruiting
Austin Retina Associates ( Site 0080) San Marcos Texas Recruiting
Retina Consultants of Texas ( Site 0029) Schertz Texas Recruiting
Retina Consultants ( Site 0104) Charleston West Virginia Recruiting
Fundacion Zambrano ( Site 0402) CABA Argentina Recruiting
Eyeclinic Albury-Wodonga ( Site 2204) Albury New South Wales Recruiting
Marsden Eye Specialists ( Site 2200) Parramatta New South Wales Recruiting
Sydney Retina Clinic and Day Surgery ( Site 2203) Sydney New South Wales Recruiting
Bristol Eye Hospital ( Site 0902) Bristol Bristol, City of Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07705555 on ClinicalTrials.gov ↗ ← All trials in the UK