A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

Last updated: March 24, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Macular Edema

Treatment

RO7200220

Vamikibart

Sham

Clinical Study ID

NCT05642312
GR44277
  • Ages > 18
  • All Genders

Study Summary

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female participants: Agreement to remain abstinent (refrain from heterosexualintercourse) 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 anyanatomical type (anterior, intermediate, posterior, panuveitis)

  • BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment DiabeticRetinopathy Study (EDTRS)-like charts

Exclusion

Exclusion Criteria:

  • Evidence of active or latent syphilis infection

  • Evidence of active or latent tuberculosis infection and/or positive tuberculosisassay, 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 ofretina, 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 capsulotomywithin 3 months of Day 1

  • Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days priorto Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 monthsprior 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 implantin 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 duringthe study period to prevent vision loss

Study Design

Total Participants: 245
Treatment Group(s): 3
Primary Treatment: RO7200220
Phase: 3
Study Start date:
January 09, 2023
Estimated Completion Date:
July 08, 2025

Connect with a study center

  • LKH-Univ.Klinikum Graz

    Graz, 8036
    Austria

    Site Not Available

  • LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

    Graz, 8036
    Austria

    Site Not Available

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021
    Austria

    Site Not Available

  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

    Linz, 4021
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

    Wien, 1090
    Austria

    Site Not Available

  • Hospital das Clinicas - UFMG; Pediatria

    Belo Horizonte, MG 30130-100
    Brazil

    Site Not Available

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais 30130-100
    Brazil

    Site Not Available

  • Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

    Sao Paulo, SP 04023-062
    Brazil

    Site Not Available

  • CEMAPE - Centro Médico

    Sao Paulo, São Paulo 04084-002
    Brazil

    Site Not Available

  • Retina Clinic

    Sao Paulo, São Paulo 01427-002
    Brazil

    Site Not Available

  • Universidade Federal de Sao Paulo - UNIFESP*X

    Sao Paulo, São Paulo 04023-062
    Brazil

    Site Not Available

  • Fiocruz - Fundação Oswaldo Cruz

    Rio de Janeiro, 21040-360
    Brazil

    Site Not Available

  • Alberta Retina Consultants

    Edmonton, Alberta T5H 0X5
    Canada

    Site Not Available

  • Ivey Eye Institute

    London, Ontario N6A 4V2
    Canada

    Site Not Available

  • University of Ottawa

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Kensington Vision and Research Centre

    Toronto, Ontario M5T 3A9
    Canada

    Site Not Available

  • St. Michael's Hospital; Department of Ophthalmology

    Toronto, Ontario M5C 2T2
    Canada

    Site Not Available

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • McGill University Health Center

    Montreal, Quebec H4A 3S5
    Canada

    Site Not Available

  • CHU de Quebec-Universite Laval

    Quebec, G1S 4L8
    Canada

    Site Not Available

  • Beijing Tongren Hospital

    Beijing, 100730
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing City, 100032
    China

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun City, 130041
    China

    Site Not Available

  • The Second Hospital of Jilin University; ophthalmology department

    Changchun City, 130041
    China

    Site Not Available

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou City, 510060
    China

    Site Not Available

  • Second Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou,
    China

    Site Not Available

  • Second Affiliated Hospital Zhejiang University College of Medicine; Ophthalmology

    Hangzhou,
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin City, 300070
    China

    Site Not Available

  • Eye Hospital, Wenzhou Medical University

    Wenzhou City, 325027
    China

    Site Not Available

  • Ren Min Hospital Affiliated Wu Han University

    Wuhan, 430060
    China

    Site Not Available

  • Wuxi No.2 People's Hospital

    Wuxi, 214000
    China

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Medical Center; Opthalmology

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah MC

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Hadassah MC; Ophtalmology

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Meir Medical Center; Ophtalmology

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Rabin MC

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Rabin MC; Ophtalmology

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 7660101
    Israel

    Site Not Available

  • Kaplan Medical Center; Ophtalmology

    Rehovot, 7660101
    Israel

    Site Not Available

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky MC; Ophtalmology

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Assuta Hashalom Medical Center

    Tel Aviv-Yafo, 6789140
    Israel

    Site Not Available

  • AUSL ? IRCCS Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna 42100
    Italy

    Site Not Available

  • AUSL ? IRCCS Santa Maria Nuova; Immunologia Oculare

    Reggio Emilia, Emilia-Romagna 42100
    Italy

    Site Not Available

  • ASL 4 SSR Ospedale Santa Maria di Montallegro

    Rapallo, Liguria 16035
    Italy

    Site Not Available

  • ASL 4 SSR Ospedale Santa Maria di Montallegro; SC Oculistica, SSD Uveiti e Infiammazioni Oculari

    Rapallo, Liguria 16035
    Italy

    Site Not Available

  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

    Milano, Lombardia 20157
    Italy

    Site Not Available

  • Asst Fatebenefratelli Sacco

    Milano, Lombardia 20157
    Italy

    Site Not Available

  • Irccs Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Irccs Ospedale San Raffaele;U.O. Oculistica

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Ajou University Medical Center

    Gyeonggi-do, 16499
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Kim's Eye Hospital

    Seoul, 07301
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul St Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • CODET Vision Institute

    Tijuana, BAJA California 22010
    Mexico

    Site Not Available

  • Health Pharma Professional Research

    Cdmx, Mexico CITY (federal District) 03100
    Mexico

    Site Not Available

  • Hospital de la Ceguera APEC

    Mexico, D.F., Mexico CITY (federal District) 04030
    Mexico

    Site Not Available

  • Instituto de Oftalmologia Monterrey - Vision100 (IOM)

    Monterrey, Nuevo LEON 64630
    Mexico

    Site Not Available

  • Het Oogziekenhuis Rotterdam

    Rotterdam, 3011 BH
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631
    Poland

    Site Not Available

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594
    Poland

    Site Not Available

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

    Krakow, 31-501
    Poland

    Site Not Available

  • SPSK nr 1 w Lublinie

    Lublin, 20-079
    Poland

    Site Not Available

  • SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego

    Lublin, 20-079
    Poland

    Site Not Available

  • SPEKTRUM Osrodek Okulistyki Klinicznej

    Wroclaw, 53-334
    Poland

    Site Not Available

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548
    Portugal

    Site Not Available

  • Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Hospital de Santa Maria; Servico de Oftalmologia

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Instituto de Oftalmologia Dr. Gama Pinto

    Lisboa, 1169-019
    Portugal

    Site Not Available

  • Mackay Memorial Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital; Ophthalmology

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital; Ophthalmology

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - Linkou; Ophthalmology

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Sussex Eye Hospital

    Brighton, BN2 5BF
    United Kingdom

    Site Not Available

  • Bristol Eye Hospital

    Bristol, BS1 2LX
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

    Liverpool, L7 8YE
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Western Eye Hospital

    London, NW1 5QH
    United Kingdom

    Site Not Available

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ
    United Kingdom

    Site Not Available

  • Maidstone Hospital; Eye Unit

    Maidstone, Kent, ME16 9QQ
    United Kingdom

    Site Not Available

  • James Cook Hospital

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California 90095-7000
    United States

    Site Not Available

  • Kaiser Permanente Southern California

    Los Angeles, California 90027
    United States

    Site Not Available

  • Kaiser Permanente Southern California

    Riverside, California 92505
    United States

    Site Not Available

  • Colorado Retina Associates, PC

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711-1141
    United States

    Site Not Available

  • Emory Eye Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern Uni

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Cumberland Valley Retina PC

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts 01432
    United States

    Site Not Available

  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

    Edina, Minnesota 55435
    United States

    Site Not Available

  • VitreoRetinal Surgery, PLLC.

    Minneapolis, Minnesota 55435
    United States

    Site Not Available

  • Truhlsen Eye Institute

    Omaha, Nebraska 68106-5540
    United States

    Site Not Available

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • The Retina Consultants

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Wake Forest Baptist Health Eye Centre

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Investigational Drug Services

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon 97227
    United States

    Site Not Available

  • Oregon Health & Science Uni

    Portland, Oregon 97239
    United States

    Site Not Available

  • Erie Retina Research

    Erie, Pennsylvania 16507-1429
    United States

    Site Not Available

  • Erie Retinal Surgery

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Tennessee Retina PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt Eye Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Wagner Kapoor Institute

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

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