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

NCT ID NCT06990399

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests an experimental drug called tabirafusp alfa (KSI-101) given as an eye injection for people with macular edema (swelling) caused by inflammation. The study will compare the drug to a sham (fake) injection in 600 participants to see if it improves vision and reduces swelling over 24 weeks. The goal is to find a safe and effective treatment for this vision-threatening condition.

What this could mean

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

Active substance
tabirafusp alfa (KSI-101)
What this could lead to
If it works, this could offer a new treatment option for people with vision loss due to inflammation-related macular edema.
What could go wrong
This is a late-stage trial, but the drug is still experimental. It may not improve vision better than sham injections, and eye injections carry risks like infection or inflammation.
Why investors are watching

Kodiak Sciences is a very small publicly traded company, and its future hinges on this Phase 3 trial of the drug tabirafusp alfa (KSI-101) for macular edema caused by inflammation. The trial tests whether the drug, given as an eye injection, safely reduces swelling in the retina better than a sham procedure. For a micro-cap company, this single readout can determine its financial health and ability to continue operations.

If it works: If the trial succeeds, Kodiak Sciences could have a marketable treatment for a condition with no approved therapy, which would generate revenue and attract partnerships. A positive result would validate the company's core drug platform and support its path to regulatory approval.

If it fails: If the trial fails or is delayed, Kodiak Sciences, with its limited resources, could face severe financial strain or even bankruptcy. Clinical trials often fail, and a negative outcome would likely wipe out much of the company's value.

AI-written from the trial record. Speculative, and not investment advice.

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 600 people

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

Started

Jul 2025

Expected to finish

Nov 2027

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: * Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye. * Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye. * BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye. * Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye. Exclusion Criteria: * Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD. * Active or suspected ocular or periocular infection in either eye. * Any history of or active occlusive retinal vasculitis in either eye.

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Conditions

The condition(s) this trial relates to.

Macular Edema macular retinal edema

As listed by the trial registrant

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

Macular edema secondary to inflammation

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

    54 sites in 2 countries. 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

  • AZ Retina & Vitreous Consultants

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Associated Vitreoretinal and Uveitis Consultants LLC

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Austin Retina Associates, PLLC (Austin)

    RECRUITING

    Austin, Texas, 78705, United States

  • Austin Retina Associates, PLLC (Round Rock)

    RECRUITING

    Round Rock, Texas, 78681, United States

  • California Eye Specialists Medical Group, Inc.

    RECRUITING

    Pasadena, California, 91107, United States

  • California Eye Specialists Medical Group, Inc.

    RECRUITING

    Redlands, California, 92373, United States

  • California Retina Consultants (Bakersfield)

    RECRUITING

    Bakersfield, California, 93309, United States

  • California Retina Consultants (Oxnard)

    RECRUITING

    Oxnard, California, 93036, United States

  • Cascade Medical Research Institute

    RECRUITING

    Springfield, Oregon, 97477, United States

  • Centro Oftalmologico Metropolitano

    RECRUITING

    San Juan, 00921, Puerto Rico

  • Charleston Neuroscience Institute, LLC (Charleston)

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Coastal Eye Surgeons

    RECRUITING

    Greenwich, Connecticut, 06830, United States

  • Cumberland Valley Retina Consultants

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Erie Retina Research

    RECRUITING

    Erie, Pennsylvania, 16507, United States

  • Eye Associates of New Mexico, Vision Research Center

    NOT_YET_RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Eye Clinic of Wisconsin

    RECRUITING

    Wausau, Wisconsin, 54403, United States

  • Florida Eye Clinic

    NOT_YET_RECRUITING

    Altamonte Springs, Florida, 32701, United States

  • Global Research Management, Inc.

    RECRUITING

    Glendale, California, 91204, United States

  • Midwest Eye Institute

    RECRUITING

    Carmel, Indiana, 46032, United States

  • North Carolina Retina Associates (Cary)

    RECRUITING

    Cary, North Carolina, 27511, United States

  • North Carolina Retina Associates (Wake Forest)

    RECRUITING

    Wake Forest, North Carolina, 27587, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43212, United States

  • Ophthalmic Consultants of Boston

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Ophthalmology Ltd

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Pacific Northwest Retina (Bellevue)

    RECRUITING

    Bellevue, Washington, 98004, United States

  • Pacific Northwest Retina (Silverdale)

    RECRUITING

    Silverdale, Washington, 98383, United States

  • Palmetto Retina Center (West Columbia)

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Research Network Arizona

    RECRUITING

    Scottsdale, Arizona, 85255, United States

  • Retina Associates of New York, P.C.

    RECRUITING

    New York, New York, 10075, United States

  • Retina Associates, LTD

    RECRUITING

    Elmhurst, Illinois, 60126, United States

  • Retina Consultants of Minnesota

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Retina Consultants of Southern California

    RECRUITING

    Redlands, California, 92374, United States

  • Retina Consultants of Texas (Bellaire)

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas (Katy)

    RECRUITING

    Katy, Texas, 77494, United States

  • Retina Consultants of Texas (San Antonio)

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas (Woodlands)

    RECRUITING

    The Woodlands, Texas, 77384, United States

  • Retina Consultants, PC

    RECRUITING

    Manchester, Connecticut, 06042, United States

  • Retina Group of Florida (Ft. Lauderdale)

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of New England, PC

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Retina Research Institute of Texas

    RECRUITING

    Abilene, Texas, 70606, United States

  • Retina Specialists of Colorado (RSC)

    WITHDRAWN

    Denver, Colorado, 80222, United States

  • Retina Vitreous Associates of Florida (St. Petersburg)

    RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Retinal Consultants Medical Group Inc

    RECRUITING

    Sacramento, California, 95841, United States

  • Rocky Mountain Uveitis

    RECRUITING

    Denver, Colorado, 80246, United States

  • St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)

    RECRUITING

    Palisades Park, New Jersey, 07650, United States

  • Stanford Byers Eye Institute

    NOT_YET_RECRUITING

    Palo Alto, California, 94303, United States

  • Tennessee Retina PC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates (Plano)

    RECRUITING

    Plano, Texas, 75075, United States

  • Texas Retina Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The Retina Institute

    RECRUITING

    St Louis, Missouri, 63128, United States

  • UCLA Stein Eye Institute

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSD/Jacobs Retina Center

    RECRUITING

    La Jolla, California, 92093, United States

  • UT Austin

    NOT_YET_RECRUITING

    Austin, Texas, 78712, United States

  • Vanderbilt Eye Institute

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Vision Research Solutions

    WITHDRAWN

    Philadelphia, Pennsylvania, 19141, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.