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New eye injection shows promise for blurry vision from uveitis

NCT ID NCT05642312

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested an experimental drug called vamikibart, given as an eye injection, for people with uveitic macular edema — swelling in the back of the eye caused by inflammation. 245 adults with this condition took part. The main goal was to see if the drug improves vision by at least 15 letters on an eye chart after 16 weeks, compared to a sham (fake) injection.

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

245 people

The number who actually took part.

Started

Jan 2023

Finished

Jul 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

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548, Portugal

  • ASL 4 SSR Ospedale Santa Maria di Montallegro

    Rapallo, Liguria, 16035, Italy

  • AUSL ? IRCCS Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100, Italy

  • Ajou University Medical Center

    Gyeonggi-do, 16499, South Korea

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Fatebenefratelli Sacco

    Milan, Lombardy, 20157, Italy

  • Assuta Hashalom Medical Center

    Tel Aviv, 6789140, Israel

  • Austin Clinical Research LLC

    Austin, Texas, 78750, United States

  • Beijing Tongren Hospital

    Beijing, 100730, China

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ, United Kingdom

  • Bristol Eye Hospital

    Bristol, BS1 2LX, United Kingdom

  • CEMAPE - Centro Médico

    São Paulo, São Paulo, 04084-002, Brazil

  • CHU de Quebec-Universite Laval

    Québec, G1S 4L8, Canada

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740, United States

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Erie Retina Research

    Erie, Pennsylvania, 16507-1429, United States

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027, China

  • Fiocruz - Fundação Oswaldo Cruz

    Rio de Janeiro, 21040-360, Brazil

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594, Poland

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN, United Kingdom

  • Hadassah MC

    Jerusalem, 9112001, Israel

  • Het Oogziekenhuis Rotterdam

    Rotterdam, 3011 BH, Netherlands

  • Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Hospital de la Ceguera APEC

    Mexico City, Mexico CITY (federal District), 04030, Mexico

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Instituto de Oftalmologia Dr. Gama Pinto

    Lisbon, 1169-019, Portugal

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • James Cook Hospital

    Middlesbrough, TS4 3BW, United Kingdom

  • Kaiser Permanente Southern California

    Los Angeles, California, 90027, United States

  • Kaplan Medical Center

    Rehovot, 7660101, Israel

  • Kensington Vision and Research Centre

    Toronto, Ontario, M5T 3A9, Canada

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021, Austria

  • Kim's Eye Hospital

    Seoul, 07301, South Korea

  • LKH-Univ.Klinikum Graz

    Graz, 8036, Austria

  • Mackay Memorial Hospital

    Taipei, Taiwan

  • Medizinische Universitat Wien

    Vienna, 1090, Austria

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631, Poland

  • Oregon Health & Science Uni

    Portland, Oregon, 97239, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Peking Union Medical College Hospital

    Beijing, 100032, China

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Rabin MC

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Ren Min Hospital Affiliated Wu Han University

    Wuhan, 430060, China

  • Retina Clinic

    São Paulo, São Paulo, 01427-002, Brazil

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711-1141, United States

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP, United Kingdom

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

    Krakow, 31-501, Poland

  • SPEKTRUM Osrodek Okulistyki Klinicznej

    Wroclaw, 53-334, Poland

  • SPSK nr 1 w Lublinie

    Lublin, 20-079, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Second Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, China

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai First People's Hospital

    Shanghai, 200080, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906, Israel

  • Tennessee Retina PC

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates

    Dallas, Texas, 75231, United States

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016, China

  • The Ohio State University Investigational Drug Services

    Columbus, Ohio, 43212, United States

  • The Second Hospital of Jilin University

    Changchun, 130041, China

  • Tianjin Medical University Eye Hospital

    Tianjin, 300070, China

  • Truhlsen Eye Institute

    Omaha, Nebraska, 68106-5540, United States

  • Universidade Federal de Sao Paulo - UNIFESPX

    São Paulo, São Paulo, 04023-062, Brazil

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • VitreoRetinal Surgery, PLLC.

    Minneapolis, Minnesota, 55435, United States

  • Wake Forest Baptist Health Eye Centre

    Winston-Salem, North Carolina, 27157, United States

  • Western Eye Hospital

    London, NW1 5QH, United Kingdom

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060, China

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