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New shot could ease bulging eyes in thyroid disease

NCT ID NCT06625411

Disease control Sponsor: Viridian Therapeutics, 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 19, 2026 · Updated 4 times

Summary

This Phase 3 trial tests an investigational drug called VRDN-003 for active thyroid eye disease, a condition that causes eye bulging, redness, and discomfort. The study involves 132 adults with moderate to severe symptoms. Participants receive either VRDN-003 or a placebo as a shot under the skin. The main goal is to see if the drug reduces eye bulging by at least 2 millimeters.

What this could mean

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

Active substance
VRDN-003 (a monoclonal antibody targeting IGF-1 receptor)
What this could lead to
If it works, this could provide a new treatment option for thyroid eye disease, reducing eye bulging and discomfort without the need for intravenous infusions.
What could go wrong
This is an early Phase 3 trial with only 132 participants, so results may not apply to everyone. The drug is still investigational, and side effects or lack of effectiveness are possible.

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

132 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Nov 2026

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 to 75 years

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.

Key Inclusion Criteria: * Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening * Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye * Must agree to use highly effective contraception as specified in the protocol * Female TED participants must have a negative serum pregnancy test at screening Key Exclusion Criteria: * Must not have received prior treatment with another anti-IGF-1R therapy * Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose * Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose. * Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose * Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose * Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit * Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results * Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor * Must not have a history of inflammatory bowel disease * Female TED participants who must not be pregnant or breastfeeding NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

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

Thyroid eye disease

Contacts and locations

Locations

  • A.P.J. Office

    Newport Beach, California, 92660, United States

  • Advancing Research International, LLC

    Los Angeles, California, 90023, United States

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328, United States

  • Alliance Research Institute - Canoga Park

    Canoga Park, California, 91304, United States

  • Alliance Research Institute - Lynwood

    Lynwood, California, 90262, United States

  • Amsterdam UMC

    Amsterdam, 1081 HZ, Netherlands

  • Anmed Health Services LLC

    Miami, Florida, 33193, United States

  • Asheville Clinical Research

    Asheville, North Carolina, 28803, United States

  • Baylor College of Medicine/Alkek Eye Center

    Houston, Texas, 77030, United States

  • Budapest Retina Intezet

    Budapest, 1133, Hungary

  • Byers Eye Institute at Stanford University

    Palo Alto, California, 94303, United States

  • C&A Clinical Trials Corp

    Cape Coral, Florida, 33990, United States

  • Charité Universitätsmedizin Berlin KöR

    Berlin, 13353, Germany

  • Cockerham Eye Consultants, PC

    San Diego, California, 92108, United States

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, A Coruña, 15706, Spain

  • Continental Clinical Research

    Miami, Florida, 33144, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • Erasmus Medical Center

    Rotterdam, 3015 CE, Netherlands

  • Fraser Eye Care Center

    Fraser, Michigan, 48026, United States

  • Gulf Coast Clinical Trials

    Houston, Texas, 77070, United States

  • Hospital Arruzafa / Metavisión Arruzafa, S.L

    Córdoba, 14012, Spain

  • Hospital Clínico San Carlos

    Córdoba, 14012, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41009, Spain

  • Hype Clinical Research LLC

    Miami, Florida, 33145, United States

  • Ilumina Medical Research

    Kissimmee, Florida, 34744, United States

  • Kahana Oculoplastic & Orbital Surgery

    Livonia, Michigan, 48152, United States

  • Klinikapotheke des Universitätsklinikums Gießen und Marburg GmbH (UKGM)

    Giessen, 35392, Germany

  • Marvel Clinical Research

    Huntington Beach, California, 92647, United States

  • Med-Care Research

    Miami, Florida, 33125, United States

  • Neuro-Eye Clinical Trials

    Houston, Texas, 77074, United States

  • Opthalmic Consultants of Boston

    East Weymouth, Massachusetts, 02189, United States

  • Pasadena Clinical Trials

    Pasadena, California, 91101, United States

  • Pecsi Tudomanyegyetem Klinikai Kozpont, Szemeszeti Klinika

    Pécs, 7623, Hungary

  • Roski Eye Institute, Keck School of Medicine, USC

    Los Angeles, California, 90033, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • S.L. Office

    Las Vegas, Nevada, 89144, United States

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • United Medical Research Institute

    Inglewood, California, 90301, United States

  • Universitaetsmedizin Goettingen

    Göttingen, 37075, Germany

  • University Health

    Kansas City, Missouri, 64108, United States

  • University of Washington, Eye institute

    Seattle, Washington, 98104, United States

  • Universitätsklinikum Carl- Gustav- Carus- Dresden

    Dresden, 1307, Germany

  • Vector Clinical Trials

    Sparks, Nevada, 89436, United States

  • Vision Medical Research

    Orland Park, Illinois, 60462, United States

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506, United States

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