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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515022-88-00 | EU Trial (CTIS) Number |
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The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with dry AMD with GA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonaprument | Experimental | Participants will receive vonaprument IVT injections every month during the 24-month treatment period. |
|
| Sham Group | Sham Comparator | Participants will receive Sham IVT injections every month during the 24-month treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonaprument | Drug | Form: solution for injection; Route of Administration: IVT injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits | Baseline through Month 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Confirmed BCVA ≥15-letter Loss | Baseline to Month 15 and Baseline to Month 24 | |
| Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss | Baseline through Month 24 | |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol-defined inclusion and exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Macula Institute of Arizona | Scottsdale | Arizona | 85255 | United States | ||
| Retina-Vitreous Associates Medical Group |
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Double-masked
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| Sham Administration | Other | Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection). |
|
| Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss |
| Baseline through Month 15 and Baseline through Month 24 |
| Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer | Baseline, Month 15 and 24 |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Retinal Consultants of Orange County Clinical Research Institute Inc | Fullerton | California | 92835 | United States |
| Global Research Management | Glendale | California | 91204 | United States |
| Retina Consultants Medical Group | Modesto | California | 95356 | United States |
| Northern California Retina Vitreous Associates Medical Group, Inc. | Mountain View | California | 94040 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | United States |
| Macula Retina Vitreous Research Institute | Torrance | California | 90503 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Retina Consultants of Southern Colorado PC | Colorado Springs | Colorado | 80909 | United States |
| RSC Research, LLC | Denver | Colorado | 80222 | United States |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Retina Institute | Orlando | Florida | 32806 | United States |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | United States |
| Retina Group of Florida | Sarasota | Florida | 34232 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Retina Associates of Florida | Tampa | Florida | 33609 | United States |
| Georgia Retina PC | Marietta | Georgia | 30060 | United States |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | United States |
| Retina Associates Ltd | Elmhurst | Illinois | 60126 | United States |
| University Retina | Oak Forest | Illinois | 60452 | United States |
| Springfield Clinic LLP | Springfield | Illinois | 62703 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Maine Eye Center | Portland | Maine | 04101 | United States |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Mid Atlantic Retina Specialists | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Retina Research Institute at New England Retina Consultants | Springfield | Massachusetts | 01107 | United States |
| Retina Consultants of Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Envision Ocular, LLC | Bloomfield | New Jersey | 07003 | United States |
| Mid Atlantic Retina New Jersey | Cherry Hill | New Jersey | 08054 | United States |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Long Island Vitreoretinal Consultants | Hauppauge | New York | 11788 | United States |
| Asheville Eye Associates - Retina Division | Asheville | North Carolina | 28803 | United States |
| North Carolina Retina Associates | Cary | North Carolina | 27511 | United States |
| North Carolina Retina Associates | Wake Forest | North Carolina | 27587 | United States |
| Piedmont Retina Specialists | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Retina Vitreous Center | Edmond | Oklahoma | 73013 | United States |
| Tulsa Retina Consultants | Tulsa | Oklahoma | 74114 | United States |
| Verum Research, LLC | Eugene | Oregon | 97401 | United States |
| Eyehealth Northwest Portland | Portland | Oregon | 97209 | United States |
| Cascade Medical Research Institute | Springfield | Oregon | 97477 | United States |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Palmetto Retina Center | Aiken | South Carolina | 29802 | United States |
| Retina Consultants of Charleston | Beaufort | South Carolina | 29901 | United States |
| Charleston Neuroscience Center | Charleston | South Carolina | 29414 | United States |
| Southeastern Retina Associates | Johnson City | Tennessee | 37604 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Southwest Retina Specialists | Amarillo | Texas | 79106 | United States |
| Texas Retina Associates- Arlington | Arlington | Texas | 76012 | United States |
| Austin Research Center for Retina | Austin | Texas | 78705 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Texas Retina Associates | Fort Worth | Texas | 76104 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Tennessee Retina PC | Nashville | Texas | 37203 | United States |
| Retina Consultants of Texas San Antonio | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Eye Clinic of Wisconsin | Wausau | Wisconsin | 54403 | United States |
| Eye Clinic Albury Wodonga | Albury | New South Wales | 2640 | Australia |
| Marsden Eye Specialists | Parramatta | New South Wales | 2150 | Australia |
| Strathfield Retina Clinic | Strathfield | New South Wales | 2135 | Australia |
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| Sydney Retina Clinic and Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Klinikum Klagenfurt am Wörthersee | Klagenfurt | 9020 | Austria |
| Kepler Universitätsklinikum | Linz | 4020 | Austria |
| Calgary Retina Consultants | Calgary | Alberta | T2H 0C8 | Canada |
| Alberta Retina Consultants | Edmonton | Alberta | T5H 0X5 | Canada |
| Ivey Eye Institute | London | Ontario | N6A 4V2 | Canada |
| Retina Centre of Ottawa | Ottawa | Ontario | K2B 7E9 | Canada |
| Fakultní nemocnice Královské Vinohrady | Prague | 100 34 | Czechia |
| Všeobecná fakultní nemocnice V Praze | Prague | 128 08 | Czechia |
| Axon Clinical, s.r.o. Ocni Klinika | Prague | 150 00 | Czechia |
| Groupe Hospitalier Pellegrin - CHU de Bordeaux | Bordeaux | 33076 | France |
| Centre Hospitalier Intercommunal De Créteil | Créteil | 94000 | France |
| CHU Dijon Bourgogne - Hôpital François Mitterrand | Dijon | 21079 | France |
| Centre Ophtalmologique Pôle Vision Val d'Ouest | Écully | France |
| Centre Monticelli Paradis d'Ophtalmologie | Marseille | France |
| Centre Hospitalier Universitaire de Nice | Nice | 06001 | France |
| Hôpital Lariboisière - Service d'ophtalmologie | Paris | 75010 | France |
| Centre Ophtalmologique Maison Rouge | Strasbourg | 67000 | France |
| Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde | Neubrandenburg | Mecklenburg-Vorpommern | 17036 | Germany |
| Augenzentrum am St. Franziskus-Hospital | Münster | North Rhine-Westphalia | 48145 | Germany |
| Universitäts-Klinikum Bonn | Bonn | 53127 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Tübingen, Department für Augenheilkunde | Tübingen | 72076 | Germany |
| Ganglion Medical Center | Pécs | Baranya | 7621 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Semmelweis Egyetem | Budapest | 1085 | Hungary |
| Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet Szemészet Osztály | Budapest | 1106 | Hungary |
| Budapest Retina Associates | Budapest | 1133 | Hungary |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| IRCCS MultiMedica | Milan | 20123 | Italy |
| ASST Fatebenefratelli Sacco | Milan | 20157 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia - Presidio | Roma | 00184 | Italy |
| Fondazione PTV Policlinico Tor Vergata | Rome | 00133 | Italy |
| Fondazione Policlinico Agostino Gemelli | Rome | 00168 | Italy |
| Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis | Tilburg | 5042 AD | Netherlands |
| Southern Eye Specialists | Christchurch | Canterbury | 8013 | New Zealand |
| Capital Eye Specialists | Te Aro | Wellington Region | 6011 | New Zealand |
| Oftalmika Sp.Zo.O. | Bydgoszcz | 85-631 | Poland |
| Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O. | Olsztyn | 10-424 | Poland |
| Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o. | Rzeszów | 35-017 | Poland |
| Caminomed Sp. Z O.O. | Tarnowskie Góry | 42-600 | Poland |
| Warszawski Szpital Okulistyczny | Warsaw | 01-258 | Poland |
| Oftalvist IMED Burjassot | Valencia | Burjassot | 46100 | Spain |
| Institut Català de Retina | Barcelona | 08017 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de la Arruzafa - Metavisión Arruzafa | Córdoba | 14012 | Spain |
| Clínica Baviera | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | 28222 | Spain |
| Hospital Universitari General de Catalunya - Valles Ophthalmology Research - OMIQ Research | Sant Cugat del Vallès | 08195 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Moorfields Eye Hospital NHS foundation Trust | Greater London | London | EC1V 2PD | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| The Retina Clinic London | London | W1G 9AX | United Kingdom |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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