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New eye drug could save sight for millions with diabetes

NCT ID NCT06270836

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an eye injection called tarcocimab in 255 people with diabetic retinopathy, a diabetes complication that can damage vision. Participants received either the drug or a sham (fake) injection. The goal was to see if the drug improves the severity of the disease and prevents sight-threatening complications. The trial is complete, but results are not yet available.

What this could mean

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

Active substance
tarcocimab tedromer (injected into the eye)
What this could lead to
If it works, this could offer a new way to slow or stop vision loss from diabetic retinopathy, reducing the need for more invasive treatments.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug is injected directly into the eye, which carries risks like infection or inflammation. It may not work better than existing treatments.

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

255 people

The number who actually took part.

Started

May 2024

Finished

Feb 2026

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: * Signed informed consent prior to participation in the study. * Type 1 or 2 diabetes mellitus and HbA1c of ≤12%. * DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator. * CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR * CST \>320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1. Exclusion Criteria: * Prior PRP in the Study Eye. * Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye. * Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1. * Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1. * Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye. * History of vitreoretinal surgery in the Study Eye. * History of uveitis in either eye. * Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening. * Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP. * Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study. * Active or suspected ocular or periocular infection or inflammation. * Women who are pregnant or lactating or intending to become pregnant during the study. * History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. * Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event. * Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest. * Other protocol-specified exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

diabetic retinopathy eye disorder retinal degeneration retinal disorder vision disorder

As listed by the trial registrant

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

Diabetic retinopathy

Contacts and locations

Locations

  • Asheville Eye Associates

    Asheville, North Carolina, 28803, United States

  • Associated Vitreoretinal and Uveitis Consultants

    Carmel, Indiana, 46290, United States

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Austin Retina Associates, PLLC (Austin)

    Austin, Texas, 78705-1169, United States

  • Austin Retina Associates, PLLC (Round Rock)

    Round Rock, Texas, 78681, United States

  • Cascade Medical Research Institute

    Springfield, Oregon, 97477, United States

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Charleston Neuroscience Institute

    Charleston, South Carolina, 29414, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Emanuelli Research & Development Center, LLC

    Arecibo, 00612, Puerto Rico

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Erie Retina Research

    Erie, Pennsylvania, 16507, United States

  • Florida Eye Associates

    Melbourne, Florida, 32901, United States

  • Global Research Management, Inc. - Lugene Eye Institute

    Glendale, California, 91204, United States

  • North Carolina Retina Associates (Cary)

    Cary, North Carolina, 27511, United States

  • North Carolina Retina Associates (Wake Forest)

    Wake Forest, North Carolina, 27587, United States

  • Pacific Northwest Retina (Bellevue)

    Bellevue, Washington, 98004, United States

  • Panhandle Eye Group, LLP. - Southwest Retina Specialists

    Amarillo, Texas, 79106, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Retina Associates SW

    Tucson, Arizona, 85704, United States

  • Retina Consultants of Nevada

    Henderson, Nevada, 89052, United States

  • Retina Consultants of Orange County

    Fullerton, California, 92835, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Consultants of Texas (Bellaire)

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas (Katy)

    Katy, Texas, 77494, United States

  • Retina Consultants of Texas (San Antonio)

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas (Woodlands)

    The Woodlands, Texas, 77384, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retinal Consultants Medical Group, Inc.

    Modesto, California, 95356, United States

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95825, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southeastern Retina Associates PC

    Knoxville, Tennessee, 37922, United States

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204, United States

  • Springfield Clinic LLP

    Springfield, Illinois, 62703, United States

  • Star Vision Research

    Burleson, Texas, 76028, United States

  • Texas Retina Associates

    Plano, Texas, 75075, United States

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