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New eye injection shows promise for blinding swelling condition

NCT ID NCT05642325

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an eye injection called vamikibart in 256 people with uveitic macular edema, a condition where swelling in the eye damages vision. Participants received either the drug or a sham procedure. The main goal was to see if vision improved by at least 15 letters on an eye chart after 16 weeks. The trial is complete, and results will show if this treatment can safely reduce swelling and improve sight.

What this could mean

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

Active substance
vamikibart (eye injection)
What this could lead to
If it works, this could offer a new treatment option for people with uveitic macular edema to improve vision and reduce swelling in the eye.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The treatment involves eye injections, which carry risks like infection or inflammation. It may not work for everyone.

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

256 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

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: * Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol * Diagnosis of macular edema associated with non-infectious uveitis (NIU) * Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) * BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts Exclusion Criteria: * Evidence of active or latent syphilis infection * Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis * Serious acute or chronic medical or psychiatric illness * History of major ocular and non-ocular surgical procedures * Uncontrolled IOP or glaucoma or chronic hypotony * Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images * Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1 * Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1 * Topical corticosteroids and/or topical NSAID \> 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1 * Diagnosis of macular edema due to any cause other than NIU * Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss

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As listed by the trial registrant

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

Uveitic macular edema

Contacts and locations

Locations

  • "Kazakh "Badge of H?nour" Scientific R?s??r?h Institute of ??? diseases" LLP

    Almaty, 050012, Kazakhstan

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548, Portugal

  • AUSL ? IRCCS Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100, Italy

  • Advanced Research

    Deerfield Beach, Florida, 33064, United States

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • Asst Fatebenefratelli Sacco

    Milan, Lombardy, 20157, Italy

  • Barnet Dulaney Perkins Eye Center

    Sun City, Arizona, 85351, United States

  • Beijing Tongren Hospital

    Beijing, 100730, China

  • Berner Augenklinik

    Bern, Switzerland

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

  • CHU Nantes - Hotel Dieu

    Nantes, 44093, France

  • California Eye Specialists Medical group Inc.

    Pasadena, California, 91107, United States

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Centro Privado de Ojos

    Ciudad Autonoma Buenos Aires, C1033AAW, Argentina

  • Ch Pitie Salpetriere

    Paris, 75651, France

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Consultorios Medicos Oftalmológicos

    Ciudad Autonoma Buenos Aires, C1426DQS, Argentina

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740, United States

  • Duke Eye Center

    Durham, North Carolina, 27710, United States

  • Ege Üniversitesi Tip Fakültesi

    Lzmir, 35100, Turkey (Türkiye)

  • Erie Retina Research

    Erie, Pennsylvania, 16507-1429, United States

  • Eye Surgery Associates

    Malvern, Victoria, 3144, Australia

  • Fundacion Jimenez Diaz-UTE

    Madrid, 28040, Spain

  • General Teaching Hospital Prague

    Prague, 128 08, Czechia

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 8907, Spain

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Hôpital COCHIN

    Paris, 75014, France

  • ICARE Eye Hospital & PG Institute

    Noida, Uttar Pradesh, 201301, India

  • Inselspital Bern Ophthalmologische Klinik

    Bern, 3010, Switzerland

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Japan Community Health care Organization Osaka Hospital

    Osaka, 553-0003, Japan

  • Jichi Medical University Saitama Medical Center

    Saitama, 330-0834, Japan

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 92505, United States

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280, Germany

  • Kobe University Hospital

    Hyōgo, 650-0017, Japan

  • Kyorin University Hospital

    Tokyo, 181-8611, Japan

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • L V Prasad Eye Institute

    Hyderabad, Telangana, 500034, India

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107, United States

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD, United Kingdom

  • Narayana Nethralaya Hospital

    Bangalore, Karnataka, 560010, India

  • National Defense Medical College Hospital

    Saitama, 359-8513, Japan

  • National University Hospital

    Singapore, 119074, Singapore

  • Nippon Medical School Tama Nagayama Hospital

    Tokyo, 206-8512, Japan

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040, United States

  • Oftalmologia Global

    Rosario, 2000, Argentina

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO, Argentina

  • Peking Union Medical College Hospital

    Beijing, 100032, China

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012, India

  • Pusan National University Hospital

    Busan, 602-739, South Korea

  • 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, Texas, 77401, United States

  • Retina Consultants of Texas

    Katy, Texas, 77494, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of Washington

    Fairfax, Virginia, 22031, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Specialists Victoria

    Rowville, Victoria, 3178, Australia

  • Retinal Consultants Med Group

    Sacramento, California, 95825, United States

  • Sankara Nethralaya

    Chennai, Tamil Nadu, 600006, India

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St. Franziskus Hospital

    Münster, 48145, Germany

  • Stadtspital Triemli Ophthalmologische Klinik

    Zurich, 8063, Switzerland

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016, China

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009, Australia

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitatsklinikum Koln

    Cologne, 50937, Germany

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452, United States

  • University of California, Davis, Eye Center

    Sacramento, California, 95817, United States

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105, United States

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

  • Universitäts-Augenklinik Tübingen

    Tübingen, 72076, Germany

  • Universitätskliniikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538, Germany

  • Universitätsklinik Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106, Germany

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075, Germany

  • Vista Klinik Ophthalmologische Klinik

    Binningen, 4102, Switzerland

  • Yamaguchi University Hospital

    Yamaguchi, 755-8505, Japan

  • Yokohama City University Hospital

    Kanagawa, 236-0004, Japan

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