Diabetic Retinopathy study: MK-8748 vs Aflibercept
Official title A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
ClinicalTrials.gov ID: NCT07705607
What this study is testing
What is MK-8748?
An investigational intravitreal injection being studied for diabetic macular edema.
Also referred to as EYE201, Tiespectus.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if MK‑8748 is as effective as aflibercept in treating diabetic macular edema.
- Who it's for
- Adults who have diabetic macular edema and are eligible for eye treatment trials.
- What's involved
- Participants will receive either MK‑8748 or aflibercept injections into the eye, with regular eye exams and vision tests during the study.
- Time commitment
- The trial lasts several months, with scheduled clinic visits for injections and eye evaluations throughout the study period.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Has had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or has renal failure anticipated to require hemodialysis or...
- 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...
- 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...
- Has advanced or uncontrolled glaucoma in the study eye
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Long Beach, California, United States
- Modesto, California, United States
- Sacramento, California, United States
- Waterford, Connecticut, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Winter Haven, Florida, United States
- Carmel, Indiana, United States
- West Des Moines, Iowa, United States
- Hagerstown, Maryland, United States
- Liverpool, New York, United States
- Greenville, North Carolina, United States
- Hickory, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Aiken, South Carolina, United States
- Beaufort, South Carolina, United States
- Charleston, South Carolina, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Bakersfield, California, United States; Beverly Hills, California, United States; Long Beach, California, United States; Modesto, California, United States; Sacramento, California, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.