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Can a new eye injection beat the current standard for diabetic vision loss?

NCT ID NCT07734844

Disease control Sponsor: Kodiak Sciences Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 3 trial compares an experimental drug, tabirafusp tedromer, against the standard treatment aflibercept for people with diabetic macular edema (DME), a leading cause of vision loss in diabetes. About 910 adults with DME will receive injections into the eye and be followed for one year to see which treatment better improves eyesight. The study aims to determine whether the new drug offers a more effective option for managing this condition.

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 tabirafusp tedromer (also known as KSI-501), given as an injection into the eye
What this could lead to
If it works, this could offer a new treatment option for diabetic macular edema, potentially improving vision better than current standard therapy.
What could go wrong
This is an early-phase 3 trial, so the experimental drug may not prove superior to aflibercept. Eye injections carry risks like infection, inflammation, or increased eye pressure.

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 910 people

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

Started

Aug 2026

Expected to finish

Sep 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: * DME, treatment-naïve or previously-treated * Male or female ≥18 years of age with Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12% * Capable of giving informed signed consent Exclusion Criteria: * Active iris or angle neovascularization or neovascular glaucoma in the Study Eye. * Current or history of retinal detachment (tractional or rhegmatogenous) in the Study Eye

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

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

Diabetic macular edema (DME)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Kodiak Research Center

    RECRUITING

    Glendale, California, 91204, United States

  • Kodiak Research Center

    RECRUITING

    Pasadena, California, 91107, United States

  • Kodiak Research Center

    RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Kodiak Research Center

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Kodiak Research Center

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Kodiak Research Center

    RECRUITING

    Beaufort, South Carolina, 29902, United States

  • Kodiak Research Center

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Kodiak Research Center

    RECRUITING

    Ladson, South Carolina, 29456, United States

  • Kodiak Research Center

    RECRUITING

    West Columbia, South Carolina, 29169, United States

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