Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
256 participants
INTERVENTIONAL
2023-03-23
2025-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm B
Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Vamikibart
Participants will receive vamikibart IVT injection
Arm C
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
Sham
Participants will receive a sham procedure that mimics an IVT injection.
Arm A
Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
Vamikibart
Participants will receive vamikibart IVT injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vamikibart
Participants will receive vamikibart IVT injection
Sham
Participants will receive a sham procedure that mimics an IVT injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-LaRoche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Associated Retina Consultants
Phoenix, Arizona, United States
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
California Eye Specialists Medical group Inc.
Pasadena, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, United States
University of California, Davis, Eye Center
Sacramento, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
Advanced Research
Deerfield Beach, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Duke Eye Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Erie Retina Research
Erie, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
Katy, Texas, United States
Retina Group of Washington
Fairfax, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Centro Privado de Ojos
Ciudad Autonoma Buenos Aires, , Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, , Argentina
Consultorios Medicos Oftalmológicos
Ciudad Autonoma Buenos Aires, , Argentina
Oftalmologia Global
Rosario, , Argentina
Organizacion Medica de Investigacion
San Nicolás, , Argentina
Sydney Eye Hospital
Sydney, New South Wales, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Eye Surgery Associates
Malvern, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
Peking Union Medical College Hospital
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, , China
General Teaching Hospital Prague
Prague, , Czechia
CHU Nantes - Hotel Dieu
Nantes, , France
Hopital Lariboisiere
Paris, , France
Hôpital COCHIN
Paris, , France
Ch Pitie Salpetriere
Paris, , France
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinik Heidelberg
Heidelberg, , Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck
Lübeck, , Germany
St. Franziskus Hospital
Münster, , Germany
Knappschaftsklinikum Saar GmbH
Sulzbach, , Germany
Universitäts-Augenklinik Tübingen
Tübingen, , Germany
Narayana Nethralaya Hospital
Bangalore, Karnataka, India
Sankara Nethralaya
Chennai, Tamil Nadu, India
L V Prasad Eye Institute
Hyderabad, Telangana, India
ICARE Eye Hospital & PG Institute
Noida, Uttar Pradesh, India
Postgraduate Institute of Medical Education and Research
Chandigarh, , India
AUSL ? IRCCS Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Fatebenefratelli Sacco
Milan, Lombardy, Italy
Kyushu University Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kobe University Hospital
Hyōgo, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Yokohama City University Hospital
Kanagawa, , Japan
Japan Community Health care Organization Osaka Hospital
Osaka, , Japan
The University of Osaka Hospital
Osaka, , Japan
Jichi Medical University Saitama Medical Center
Saitama, , Japan
National Defense Medical College Hospital
Saitama, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Kyorin University Hospital
Tokyo, , Japan
Nippon Medical School Tama Nagayama Hospital
Tokyo, , Japan
Yamaguchi University Hospital
Yamaguchi, , Japan
"Kazakh "Badge of H?nour" Scientific R?s??r?h Institute of ??? diseases" LLP
Almaty, , Kazakhstan
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
National University Hospital
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Fundacion Jimenez Diaz-UTE
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Inselspital Bern Ophthalmologische Klinik
Bern, , Switzerland
Berner Augenklinik
Bern, , Switzerland
Vista Klinik Ophthalmologische Klinik
Binningen, , Switzerland
Stadtspital Triemli Ophthalmologische Klinik
Zurich, , Switzerland
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ege Üniversitesi Tip Fakültesi
Lzmir, , Turkey (Türkiye)
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GR44278
Identifier Type: -
Identifier Source: org_study_id