960 Participants NeededMy employer runs this trial

MK-8748 vs Aflibercept for Macular Edema

Recruiting at 10 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option called MK-8748, an experimental therapy for diabetic macular edema (DME), a condition that can impair vision in people with diabetes. Researchers aim to determine if MK-8748 is as effective as aflibercept, a current standard treatment that doesn’t work for everyone. The trial includes different groups, with participants receiving either a low or high dose of MK-8748 or the standard dose of aflibercept. Individuals with diabetes who experience vision issues due to DME and have received a diagnosis within the last nine months might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MK-8748 has promising safety results from earlier studies. In one study, researchers tested MK-8748 on patients with branch retinal vein occlusion, a blockage in the small veins that carry blood away from the eye. The study found it to be well-tolerated, with most participants experiencing no serious side effects. This suggests MK-8748 might be safe for treating conditions like diabetic macular edema (DME).

Aflibercept is already a common treatment for DME and has a strong safety record from numerous studies. New trials are now comparing MK-8748 to aflibercept. With MK-8748 in the final stages of testing, extensive safety data indicates it could be a safe treatment option.12345

Why do researchers think this study treatment might be promising for DME?

Researchers are excited about MK-8748 for macular edema because it offers a new approach to treatment compared to the current standard, which often includes medications like aflibercept. Unlike aflibercept, which is a well-established anti-VEGF therapy, MK-8748 could potentially provide different dosing flexibility. The MK-8748 treatment plan starts with frequent doses and then adjusts based on individual response, possibly leading to a more personalized treatment regimen. This tailored approach could improve outcomes for patients by better addressing their specific needs over time.

What evidence suggests that this trial's treatments could be effective for diabetic macular edema?

Research has shown that MK-8748 is being tested as a potential treatment for diabetic macular edema (DME). This new drug is a bispecific antibody, targeting two different causes of DME. Early results suggest MK-8748 might improve vision clarity in people with DME. In this trial, participants will receive either MK-8748 or aflibercept, a common treatment. Studies comparing MK-8748 to aflibercept have demonstrated that MK-8748 has potential in improving vision without causing serious eye-related side effects. This suggests MK-8748 could be a good option for those who do not respond well to current treatments like aflibercept.12367

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for people with Type 1 or Type 2 diabetes who have diabetic macular edema (DME) causing vision loss. Participants can be new to DME treatment or have started treatment within the last 3 years, and their blood sugar levels must not be extremely high.

Inclusion Criteria

My first treatment was within the last 3 years.
I have diabetes and my HbA1c is 12% or lower.
I was diagnosed with diabetic macular edema within the last 9 months and have not had treatment.
See 1 more

Exclusion Criteria

I have had kidney failure needing a transplant or dialysis, or expect to need dialysis soon.
I have not had a stroke or heart attack in the past 6 months.
I have had steroid treatment or YAG laser for cataract surgery complications in the last 90 days.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 initial administrations of MK-8748 or aflibercept every 4 weeks, then continue every 8 weeks until week 48. After week 48, treatment intervals are personalized based on response, up to week 100.

100 weeks
5 visits every 4 weeks, then every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aflibercept
  • MK-8748

Trial Overview

The study compares a new medicine called MK-8748 to an existing standard treatment, aflibercept, in treating vision problems from DME. Participants are randomly assigned to receive one of these treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: MK-8748 Low DoseExperimental Treatment1 Intervention
Group II: MK-8748 High DoseExperimental Treatment1 Intervention
Group III: Aflibercept 2 mgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

A Clinical Trial of MK-8748 Compared to Aflibercept in ...

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 ...

Merck Announces Initiation of Pivotal Phase 2b/3 Trial ...

MK-8748 (also known as Tiespectus, EYE201) is a novel investigational bispecific antibody with a dual mechanism that directly activates the Tie2 ...

Trial | NCT06664502

This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular ...

Merck launches phase 2b/3 MALBEC trial of MK-8748 in ...

The primary endpoint of the trial is mean change in best-corrected visual acuity (BCVA) from baseline to Year 1 in the study eye of the ...

Clinical Trial Update July/August 2026

Purpose: To evaluate the efficacy and safety of intravitreal tiespectus (EYE201/MK-8748) compared to aflibercept 2 mg (Eylea; Regeneron) in ...

A Clinical Trial of MK-8748 Compared to Aflibercept in ...

The main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME. Participant safety is the priority.

MSD Announces Initiation of Pivotal Phase 2b/3 Trial ...

MK-8748 in patients with ・ further vision loss due to continued vascular leakage,” MK-8748 has the ・ with serious retinal diseases.”