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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501793-19-00 | EU Trial (CTIS) Number |
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This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 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. |
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| Arm B | Experimental | Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. |
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| Arm C | Sham Comparator | Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vamikibart | Drug | Participants will receive vamikibart IVT injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20 | Week 20 | |
| Change from baseline in BCVA at Week 16 | Week 16 | |
| Change from baseline in central subfield thickness (CST) at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California | Los Angeles | California | 90027 | United States | ||
| Colorado Retina Associates, PC |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Sham | Other | Participants will receive a sham procedure that mimics an IVT injection. |
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| Week 16 |
| Change from Baseline in BCVA at Weeks 20 and 52 | Weeks 20 and 52 |
| Change from baseline in CST at Weeks 20 and 52 | Weeks 20 and 52 |
| Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52 | Weeks 16 and 52 |
| Time to rescue treatment | Up to Week 52 |
| Number of rescue treatments received | Up to Week 52 |
| Type of rescue treatments received | Up to Week 52 |
| Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52 | Weeks 16 and 52 |
| Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52 | Weeks 16 and 52 |
| Number of PRN injections received | Up to Week 52 |
| Time to first PRN injection | Up to Week 52 |
| Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 | Weeks 16 and 52 |
| Percentage of participants with ocular adverse events (AEs) | Up to Week 52 |
| Percentage of participants with non-ocular AEs | Up to Week 52 |
| Percent change from baseline in corneal endothelial cell density at Week 24 | Week 24 |
| Percentage of participants with adverse events of special interest (AESIs) | Up to Week 52 |
| Percent change from baseline in corneal endothelial cell density at Week 52 | Week 52 |
| Aqueous humor (AH) concentration of vamikibart | Up to Week 52 |
| Serum concentration of vamikibart | Up to Week 52 |
| Anti-drug antibody titer to vamikibart | Baseline to Week 52 |
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711-1141 | United States |
| Cumberland Valley Retina PC | Hagerstown | Maryland | 21740 | United States |
| VitreoRetinal Surgery, PLLC. | Minneapolis | Minnesota | 55435 | United States |
| Truhlsen Eye Institute | Omaha | Nebraska | 68106-5540 | United States |
| Envision Ocular, LLC | Bloomfield | New Jersey | 07003 | United States |
| Wake Forest Baptist Health Eye Centre | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Investigational Drug Services | Columbus | Ohio | 43212 | United States |
| Oregon Health & Science Uni | Portland | Oregon | 97239 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16507-1429 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | United States |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| LKH-Univ.Klinikum Graz | Graz | 8036 | Austria |
| Kepler Universitätskliniken GmbH - Med Campus III | Linz | 4021 | Austria |
| Medizinische Universitat Wien | Vienna | 1090 | Austria |
| Retina Clinic | São Paulo | São Paulo | 01427-002 | Brazil |
| Universidade Federal de Sao Paulo - UNIFESPX | São Paulo | São Paulo | 04023-062 | Brazil |
| CEMAPE - Centro Médico | São Paulo | São Paulo | 04084-002 | Brazil |
| Fiocruz - Fundação Oswaldo Cruz | Rio de Janeiro | 21040-360 | Brazil |
| Kensington Vision and Research Centre | Toronto | Ontario | M5T 3A9 | Canada |
| Hôpital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| CHU de Quebec-Universite Laval | Québec | G1S 4L8 | Canada |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| Beijing Tongren Hospital | Beijing | 100730 | China |
| The Second Hospital of Jilin University | Changchun | 130041 | China |
| The First Affiliated Hospital, Chongqing Medical University | Chongqing | 400016 | China |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | 510060 | China |
| Second Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| Tianjin Medical University Eye Hospital | Tianjin | 300070 | China |
| Eye Hospital, Wenzhou Medical University | Wenzhou | 325027 | China |
| Ren Min Hospital Affiliated Wu Han University | Wuhan | 430060 | China |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Hadassah MC | Jerusalem | 9112001 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Rabin MC | Petah Tikva | 4941492 | Israel |
| Kaplan Medical Center | Rehovot | 7660101 | Israel |
| Tel Aviv Sourasky MC | Tel Aviv | 6423906 | Israel |
| Assuta Hashalom Medical Center | Tel Aviv | 6789140 | Israel |
| AUSL ? IRCCS Santa Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| ASL 4 SSR Ospedale Santa Maria di Montallegro | Rapallo | Liguria | 16035 | Italy |
| Irccs Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Asst Fatebenefratelli Sacco | Milan | Lombardy | 20157 | Italy |
| Hospital de la Ceguera APEC | Mexico City | Mexico CITY (federal District) | 04030 | Mexico |
| Het Oogziekenhuis Rotterdam | Rotterdam | 3011 BH | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| OFTALMIKA Sp. z o.o | Bydgoszcz | 85-631 | Poland |
| Gabinet Okulistyczny Prof Edward Wylegala | Katowice | 40-594 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej | Krakow | 31-501 | Poland |
| SPSK nr 1 w Lublinie | Lublin | 20-079 | Poland |
| SPEKTRUM Osrodek Okulistyki Klinicznej | Wroclaw | 53-334 | Poland |
| AIBILI - Association for Innovation and Biomedical Research on Light | Coimbra | 3000-548 | Portugal |
| Instituto de Oftalmologia Dr. Gama Pinto | Lisbon | 1169-019 | Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | 16499 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Kim's Eye Hospital | Seoul | 07301 | South Korea |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Mackay Memorial Hospital | Taipei | Taiwan |
| Chang Gung Medical Foundation - Linkou | Taoyuan | 333 | Taiwan |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Bristol Eye Hospital | Bristol | BS1 2LX | United Kingdom |
| Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire | GL1 3NN | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Western Eye Hospital | London | NW1 5QH | United Kingdom |
| James Cook Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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