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New eye drug aims to restore vision in Diabetes-Related swelling

NCT ID NCT07705607

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This phase 3 trial compares an experimental drug, MK-8748, to the standard treatment aflibercept for diabetic macular edema (DME), a condition where fluid buildup in the retina blurs vision. About 1,100 adults with diabetes and vision loss from DME receive either MK-8748 or aflibercept as eye injections. The main goal is to see if MK-8748 improves visual acuity as much as aflibercept over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called MK-8748 (also known as EYE201 or Tiespectus), given as an eye injection
What this could lead to
If MK-8748 works as well as or better than aflibercept, it could offer a new treatment option for people with diabetic macular edema who do not respond well to current therapies.
What could go wrong
This is a phase 3 trial, but MK-8748 is still experimental. It may not prove as effective as aflibercept, and eye injections carry risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,104 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema diabetic retinopathy Macular Edema macular retinal edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic retinopathy Macular edema

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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