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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501794-39-00 | 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-LaRoche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States | ||
| Barnet Dulaney Perkins Eye Center |
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 |
| 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 |
| Percent change from baseline in corneal endothelial cell density at Week 24 | Week 24 |
| Percentage of participants with non-ocular AEs | Up to Week 52 |
| 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 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| California Eye Specialists Medical group Inc. | Pasadena | California | 91107 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Kaiser Permanente Riverside Medical Center | Riverside | California | 92505 | United States |
| University of California, Davis, Eye Center | Sacramento | California | 95817 | United States |
| Retinal Consultants Med Group | Sacramento | California | 95825 | United States |
| Advanced Research | Deerfield Beach | Florida | 33064 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Cumberland Valley Retina PC | Hagerstown | Maryland | 21740 | United States |
| University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16507-1429 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Retina Group of Washington | Fairfax | Virginia | 22031 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Centro Privado de Ojos | Ciudad Autonoma Buenos Aires | C1033AAW | Argentina |
| Buenos Aires Mácula | Ciudad Autonoma Buenos Aires | C1061AAE | Argentina |
| Consultorios Medicos Oftalmológicos | Ciudad Autonoma Buenos Aires | C1426DQS | Argentina |
| Oftalmologia Global | Rosario | 2000 | Argentina |
| Organizacion Medica de Investigacion | San Nicolás | C1015ABO | Argentina |
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| Centre For Eye Research Australia | East Melbourne | Victoria | 3002 | Australia |
| Eye Surgery Associates | Malvern | Victoria | 3144 | Australia |
| Retina Specialists Victoria | Rowville | Victoria | 3178 | Australia |
| The Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| Beijing Tongren Hospital | Beijing | 100730 | China |
| The First Affiliated Hospital, Chongqing Medical University | Chongqing | 400016 | China |
| General Teaching Hospital Prague | Prague | 128 08 | Czechia |
| CHU Nantes - Hotel Dieu | Nantes | 44093 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Hôpital COCHIN | Paris | 75014 | France |
| Ch Pitie Salpetriere | Paris | 75651 | France |
| Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Universitatsklinikum Koln | Cologne | 50937 | Germany |
| Universitätsklinikum Freiburg, Klinik für Augenheilkunde | Freiburg im Breisgau | 79106 | Germany |
| Universitätsmedizin Göttingen Georg-August-Universität | Göttingen | 37075 | Germany |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitätsklinik Heidelberg | Heidelberg | 69120 | Germany |
| Universitätskliniikum Schleswig-Holstein, Campus Lübeck | Lübeck | 23538 | Germany |
| St. Franziskus Hospital | Münster | 48145 | Germany |
| Knappschaftsklinikum Saar GmbH | Sulzbach | 66280 | Germany |
| Universitäts-Augenklinik Tübingen | Tübingen | 72076 | Germany |
| Narayana Nethralaya Hospital | Bangalore | Karnataka | 560010 | India |
| Sankara Nethralaya | Chennai | Tamil Nadu | 600006 | India |
| L V Prasad Eye Institute | Hyderabad | Telangana | 500034 | India |
| ICARE Eye Hospital & PG Institute | Noida | Uttar Pradesh | 201301 | India |
| Postgraduate Institute of Medical Education and Research | Chandigarh | 160012 | India |
| AUSL ? IRCCS Santa Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Irccs Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Asst Fatebenefratelli Sacco | Milan | Lombardy | 20157 | Italy |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Hyōgo | 650-0017 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8520 | Japan |
| Yokohama City University Hospital | Kanagawa | 236-0004 | Japan |
| Japan Community Health care Organization Osaka Hospital | Osaka | 553-0003 | Japan |
| The University of Osaka Hospital | Osaka | 565-0871 | Japan |
| Jichi Medical University Saitama Medical Center | Saitama | 330-0834 | Japan |
| National Defense Medical College Hospital | Saitama | 359-8513 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Kyorin University Hospital | Tokyo | 181-8611 | Japan |
| Nippon Medical School Tama Nagayama Hospital | Tokyo | 206-8512 | Japan |
| Yamaguchi University Hospital | Yamaguchi | 755-8505 | Japan |
| "Kazakh "Badge of H?nour" Scientific R?s??r?h Institute of ??? diseases" LLP | Almaty | 050012 | Kazakhstan |
| AIBILI - Association for Innovation and Biomedical Research on Light | Coimbra | 3000-548 | Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| National University Hospital | Singapore | 119074 | Singapore |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 8907 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Fundacion Jimenez Diaz-UTE | Madrid | 28040 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Inselspital Bern Ophthalmologische Klinik | Bern | 3010 | Switzerland |
| Berner Augenklinik | Bern | Switzerland |
| Vista Klinik Ophthalmologische Klinik | Binningen | 4102 | Switzerland |
| Stadtspital Triemli Ophthalmologische Klinik | Zurich | 8063 | Switzerland |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation - Linkou | Taoyuan | 333 | Taiwan |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Ege Üniversitesi Tip Fakültesi | Lzmir | 35100 | Turkey (Türkiye) |
| Moorfields Eye Hospital NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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