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 (6)
Facility
City
Region
Status
Global Research Management ( Site 0066)
Glendale
California
Recruiting
Retina Specialists of Colorado ( Site 0068)
Denver
Colorado
Recruiting
Mid Atlantic Retina ( Site 0062)
Hagerstown
Maryland
Recruiting
Envision Ocular, LLC ( Site 0039)
Bloomfield
New Jersey
Recruiting
Retina Associates of Western NY, PC ( Site 0038)
Rochester
New York
Recruiting
Southeastern Retina Associates PC ( Site 0071)
Johnson City
Tennessee
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.