A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
NCT ID: NCT05642312
Last Updated: 2025-11-21
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
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COMPLETED
PHASE3
245 participants
INTERVENTIONAL
2023-01-09
2025-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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.
Interventions
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Vamikibart
Participants will receive vamikibart IVT injection
Sham
Participants will receive a sham procedure that mimics an IVT injection.
Other Intervention Names
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Eligibility Criteria
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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
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Kaiser Permanente Southern California
Los Angeles, California, United States
Colorado Retina Associates, PC
Lakewood, Colorado, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, United States
Truhlsen Eye Institute
Omaha, Nebraska, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Investigational Drug Services
Columbus, Ohio, United States
Oregon Health & Science Uni
Portland, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Austin Clinical Research LLC
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
LKH-Univ.Klinikum Graz
Graz, , Austria
Kepler Universitätskliniken GmbH - Med Campus III
Linz, , Austria
Medizinische Universitat Wien
Vienna, , Austria
Retina Clinic
São Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo, Brazil
CEMAPE - Centro Médico
São Paulo, São Paulo, Brazil
Fiocruz - Fundação Oswaldo Cruz
Rio de Janeiro, , Brazil
Kensington Vision and Research Centre
Toronto, Ontario, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, , Canada
Peking Union Medical College Hospital
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, , China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, , China
Shanghai First People's Hospital
Shanghai, , China
Tianjin Medical University Eye Hospital
Tianjin, , China
Eye Hospital, Wenzhou Medical University
Wenzhou, , China
Ren Min Hospital Affiliated Wu Han University
Wuhan, , China
Rambam Medical Center
Haifa, , Israel
Hadassah MC
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin MC
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky MC
Tel Aviv, , Israel
Assuta Hashalom Medical Center
Tel Aviv, , Israel
AUSL ? IRCCS Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy
ASL 4 SSR Ospedale Santa Maria di Montallegro
Rapallo, Liguria, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Fatebenefratelli Sacco
Milan, Lombardy, Italy
Hospital de la Ceguera APEC
Mexico City, Mexico CITY (federal District), Mexico
Het Oogziekenhuis Rotterdam
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, , Poland
SPSK nr 1 w Lublinie
Lublin, , Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, , Poland
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, , Portugal
Instituto de Oftalmologia Dr. Gama Pinto
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Ajou University Medical Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Kim's Eye Hospital
Seoul, , South Korea
Taipei Veterans General Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Bristol Eye Hospital
Bristol, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Western Eye Hospital
London, , United Kingdom
James Cook Hospital
Middlesbrough, , United Kingdom
Countries
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Other Identifiers
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2022-501793-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
GR44277
Identifier Type: -
Identifier Source: org_study_id
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