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New hope for wet AMD: two novel drugs enter final testing phase

NCT ID NCT06556368

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This Phase 3 study tests two new drugs, tarcocimab tedromer and tabirafusp tedromer, against the standard treatment aflibercept for wet age-related macular degeneration (AMD). The trial involves 675 participants who have not been treated before. The goal is to see if the new drugs improve vision better or require fewer injections than the current standard.

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 (KSI-301) and tabirafusp tedromer (KSI-501), given as eye injections
What this could lead to
If successful, these new drugs could offer a more effective or longer-lasting treatment option for wet AMD, potentially reducing the number of injections needed.
What could go wrong
This is a Phase 3 trial, so results are not yet known. The new drugs may not be better than the existing treatment (aflibercept) and could have unexpected side effects.

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 675 people

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

Started

Aug 2024

Expected to finish

Aug 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

50 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: * Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening * BCVA ETDRS score between 78 and 25 letters (Snellen equivalent \~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1. * Capable of giving signed informed consent. Exclusion Criteria: * BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular) * Fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asheville Eye Associates

    Asheville, North Carolina, 28803, United States

  • Associated Retina Consultants

    Gilbert, Arizona, 85297, United States

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • Associated Vitreoretinal and Uveitis Consultants LLC

    Carmel, Indiana, 46032, United States

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Austin Retina Associates, PLLC

    Austin, Texas, 78705, United States

  • Austin Retina Associates, PLLC

    Round Rock, Texas, 78681, United States

  • Blue Ocean Clinical Research

    Clearwater, Florida, 33761, United States

  • California Eye Specialists Medical Group, Inc.

    Pasadena, California, 91107, United States

  • California Eye Specialists Medical Group, Inc.

    Redlands, California, 92373, 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

    Mt. Pleasant, South Carolina, 29464, United States

  • Charleston Neuroscience Institute, LLC

    Beaufort, South Carolina, 29902, United States

  • Charleston Neuroscience Institute, LLC

    Charleston, South Carolina, 29414, United States

  • Charleston Neuroscience Institute, LLC

    Ladson, South Carolina, 29456, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Emanuelli Research & Development Center, LLC

    Arecibo, 00612, Puerto Rico

  • Erie Retina Research

    Erie, Pennsylvania, 16507, United States

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403, United States

  • Global Research Management, Inc. - Lugene Eye Institute

    Glendale, California, 91204, United States

  • Graystone Eye

    Hickory, North Carolina, 28602, United States

  • Illinois Retina Associates

    Oak Park, Illinois, 60304, United States

  • Long Island Vitreoretinal Consultants

    Hauppauge, New York, 11788, United States

  • Midwest Eye Institute

    Carmel, Indiana, 46290, United States

  • Mississippi Retina Associates

    Madison, Mississippi, 39110, United States

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912, United States

  • North Carolina Retina Associates

    Cary, North Carolina, 27511, United States

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587, United States

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Ophthalmology Ltd

    Sioux Falls, South Dakota, 57108, United States

  • Pacific Northwest Retina

    Bellevue, Washington, 98004, United States

  • Palmetto Retina Center

    Aiken, South Carolina, 29802, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Panhandle Eye Group, LLP. - Southwest Retina Specialists

    Amarillo, Texas, 79106, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Piedmont Retina Specialist

    Greensboro, North Carolina, 27401, United States

  • Retina Associates SW

    Tucson, Arizona, 85704, United States

  • Retina Associates of Western NY

    Rochester, New York, 14620, United States

  • Retina Associates, Ltd

    Elmhurst, Illinois, 60126, United States

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435, United States

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416, 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 Colorado

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas

    Katy, Texas, 77494, United States

  • Retina Consultants of Texas

    Schertz, Texas, 78154, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of Florida

    Sarasota, Florida, 34232, United States

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385, United States

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255, United States

  • Retina Northwest

    Portland, Oregon, 97210, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Vitreous Surgeons of CNY PC

    Liverpool, New York, 13088, United States

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95825, United States

  • Retinal Consultants Medical Group, Inc.

    Modesto, California, 95356, United States

  • Retinal Consultants of Houston dba Retina Consultants of Texas

    San Antonio, Texas, 78240, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204, United States

  • Star Vision Research

    Burleson, Texas, 76028, United States

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Texas Retina Associates

    Arlington, Texas, 76012, United States

  • Texas Retina Associates

    Fort Worth, Texas, 76104, United States

  • Texas Retina Associates

    Plano, Texas, 75075, United States

  • Texas Retina Center

    Houston, Texas, 77030, United States

  • The Retina Care Center

    Baltimore, Maryland, 21209, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • Vision Research Solutions PLLC

    Philadelphia, Pennsylvania, 19141, United States

  • Western Carolina Clinical Research, LLC

    Winston-Salem, North Carolina, 27103, United States

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