MK-8748 vs Aflibercept for Diabetic Macular Edema
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Recruiting
Phase 3
Interventional Study
Diabetic Retinopathy
Macular Edema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 960 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for people with diabetic macular edema to see if a new medicine called MK-8748 can help treat their condition. Participants will compare the effects of MK-8748 to a standard treatment called aflibercept.
Are You a Good Fit for This Trial?
You may be able to join if
- I have Type 1 or Type 2 diabetes with an HbA1c of 12% or less.
- I have experienced vision loss due to diabetic macular edema.
- If I have not received treatment for diabetic macular edema, my diagnosis was made within 9 months.
- If I have received treatment for diabetic macular edema, my first treatment was no more than 3 years ago.
You may not be able to join if
- I have had renal failure requiring dialysis or expect to need it.
- I have had a stroke or heart attack in the past 6 months.
- I was recently diagnosed with diabetes and started diabetes medication within the past 3 months.
- I have had cataract surgery in the study eye in the last 90 days.
- I have any steroid treatment or laser surgery in the study eye for cataract complications in the last 90 days.
- I have advanced or uncontrolled glaucoma in the study eye.
- I have a history of retinal detachment in the study eye.
- I have uncontrolled blood pressure at screening.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 edem…
Contacts