MK-8748 vs. aflibercept for diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, interventional trial compares MK-8748 to aflibercept for reducing vision problems caused by diabetic macular edema. Participants include adults with diabetes and at least some vision loss due to DME, with timing criteria for treatment history. The study aims to determine if MK-8748 is at least as effective as aflibercept in improving or stabilizing vision and retinal outcomes. Key safety considerations include standard exclusion criteria such as significant renal disease or recent major cardiovascular events. The trial is conducted at several regional ophthalmology centers in the United States and is sponsored by Merck Sharp & Dohme LLC.

Why it matters

Who can join: the full rules

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

Where it's running

• South Coast Retina Center ( Site 0121)
  Long Beach, California, United States Recruiting
• Retina Group of New England ( Site 0101)
  Waterford, Connecticut, United States Recruiting
• Florida Retina Institute ( Site 0035)
  Orlando, Florida, United States Recruiting
• Retina Vitreous Associates of Florida ( Site 0036)
  St. Petersburg, Florida, United States Recruiting
• Center for Retina and Macular Disease ( Site 0047)
  Winter Haven, Florida, United States Recruiting
• Associated Vitreoretinal and Uveitis Consultants ( Site 0099)
  Carmel, Indiana, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MK-8748 vs aflibercept for diabetic macular edema

  This trial tests whether MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in people with diabetes.

  Recruiting at 35 sites Phase 3 Merck Sharp & Dohme LLC · Gilbert, Arizona and 34 other locations · NCT07705555

• Treatment for diabetic retinopathy with MS-553

  This study is testing a new oral medication called MS-553 to see if it can improve vision and reduce swelling in the eyes of people with diabetic retinopathy.

  Recruiting at 3 sites Phase 1 MingSight Pharmaceuticals, Inc · Changsha, Hunan and 2 other locations · NCT04187443

• Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

  This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.

  Recruiting Phase 4 Vanderbilt University Medical Center · Nashville, Tennessee · NCT07843849

• Automated detection of diabetic retinopathy lesions in fundus photos

  This study tests a smart imaging system within the DDART device to see if it can reliably spot diabetic retinopathy lesions in color fundus photographs.

  Recruiting Democritus University of Thrace · Alexandroupoli · NCT07758582

• Retinal microvascular changes in diabetic retinopathy measured with OCTA

  This observational study tests how retinal blood vessel patterns seen on OCTA relate to vision and blood sugar control in adults with diabetic retinopathy.

  Recruiting Sohag University · Sohag · NCT07747428

• Surabgene Lomparvovec in the Suprachoroidal Space for Diabetic Retinopathy

  This study tests a one-time gene therapy called surabgene lomparvovec to see if it can help adults with non-proliferative diabetic retinopathy avoid vision-threatening events.

  Recruiting at 40 sites Phase 2/3 AbbVie · Mesa, Arizona and 39 other locations · NCT07592273

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.