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The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose bel-sar treatment arm & laser application | Experimental | High dose of bel-sar + laser application |
|
| Low dose bel-sar treatment arm & laser application | Experimental | Low dose of bel-sar + laser application |
|
| Sham control arm & sham laser | Sham Comparator | Sham injection + sham laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bel-sar | Drug | Bel-sar via suprachoroidal administration followed by laser application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach tumor progression | Tumor Progression | 65 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to composite endpoint | Tumor progression or visual acuity failure | 65 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Contact | 617-500-8864 | clinical@aurabiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Aura Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Alabama | Withdrawn | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| Aura Biosciences | View source |
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Subject, Assessor, and Sponsor masked trial.
|
| Suprachoroidal Microinjector | Device | Suprachoroidal injection device |
|
|
| Infrared Laser | Device | Laser application |
|
| Sham Infrared Laser | Device | Sham laser application |
|
| Sham Microinjector | Device | Sham injection device |
|
| UCSD Shiley Eye Institute, Jacobs Retina Center |
| Recruiting |
| La Jolla |
| California |
| 92093 |
| United States |
| Doris Stein Eye Research Center | Recruiting | Los Angeles | California | 90095 | United States |
| Stanford University School of Medicine | Recruiting | Palo Alto | California | 94303 | United States |
| Retinal Consultants Medical Group, Inc. | Recruiting | Sacramento | California | 95825 | United States |
| Bascom Palmer Eye Institute | Withdrawn | Miami | Florida | 33136 | United States |
| Retina Associates of Florida, PA | Recruiting | Tampa | Florida | 33609 | United States |
| Emory Eye Center | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| Tufts Medical Center New England Eye Center | Recruiting | Boston | Massachusetts | 02111 | United States |
| Massachusetts Eye and Ear | Recruiting | Boston | Massachusetts | 02114 | United States |
| W.K. Kellogg Eye Center - University of Michigan | Recruiting | Ann Arbor | Michigan | 48105 | United States |
| Associated Retinal Consultants (ARC) P.C. | Recruiting | Royal Oak | Michigan | 48073 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| Nebraska Medicine's Truhlsen Eye Institute | Recruiting | Omaha | Nebraska | 68105 | United States |
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
| Duke Eye Center | Recruiting | Durham | North Carolina | 27705 | United States |
| Cole Eye Institute | Recruiting | Cleveland | Ohio | 44195 | United States |
| Dean McGee Eye Institute | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Retina Consultants of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73112 | United States |
| Shields & Shields PC-Wills Eye Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Consultants of Carolina | Recruiting | Greenville | South Carolina | 29605 | United States |
| Southeastern Retina Associates | Recruiting | Chattanooga | Tennessee | 37421 | United States |
| Tennessee Retina, PC | Recruiting | Nashville | Tennessee | 37203 | United States |
| Austin Retina Associates | Recruiting | Austin | Texas | 78705 | United States |
| Texas Retina Associates | Recruiting | Dallas | Texas | 75231 | United States |
| UT, Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| Retina Associates of South Texas, P.A. | Recruiting | San Antonio | Texas | 78240 | United States |
| Retina Center of Texas | Recruiting | Southlake | Texas | 76092 | United States |
| Retina Consultants of Texas | Recruiting | The Woodlands | Texas | 77401 | United States |
| Retina Associates of Utah | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Vitreoretinal Associates of Washington | Recruiting | Bellevue | Washington | 98004 | United States |
| Pacific NW Retina | Recruiting | Burlington | Washington | 98233 | United States |
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
| University of Wisconsin Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
| Terrace Eye Centre | Recruiting | Brisbane | Queensland | 4000 | Australia |
| Eye Research Australia | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| Medical University Graz | Recruiting | Graz | 8036 | Austria |
| Medizinische Universität Wien, Department of Ophthalmology and Optometry | Recruiting | Vienna | 1090 | Austria |
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| Serac Eye and Skin Care Centre | Recruiting | Calgary | Alberta | T2V 4Y8 | Canada |
| Centre Hospitalier de l'Universite Laval | Recruiting | Québec | Quebec | G1S 4L8 | Canada |
| Fakultni Thomayerova nemocnice | Recruiting | Prague | Krč | 14059 | Czechia |
| Fakultni nemocnice Plzen | Recruiting | Pilsen | Plzenský Kraj | 32300 | Czechia |
| Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha | Recruiting | Prague | 16902 | Czechia |
| Centre Hospitalier Universitaire de Nice | Recruiting | Nice | Cedex 1 | 06001 | France |
| Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital | Recruiting | Lyon | Rhone | 69004 | France |
| Charité - Universitätsmedizin Berlin KöR | Recruiting | Berlin | 12203 | Germany |
| University Hospital Cologne (AöR) | Not yet recruiting | Cologne | 50937 | Germany |
| Universitätsmedizin Essen | Recruiting | Essen | 45147 | Germany |
| Uniklinikum Hamburg Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde | Recruiting | Lübeck | 23538 | Germany |
| Klinikum der LMU Muenchen | Recruiting | München | 80336 | Germany |
| Universitätsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
| The Chaim Sheba Medical Center | Recruiting | Tel-Hashomer | Central District | 5262100 | Israel |
| Hadassah Medical Center, Ein-Karem | Recruiting | Jerusalem | Jerusalem | 9112001 | Israel |
| AOUC Azienda Ospedaliero-Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
| Istituto Nazionale dei Tumori, Fondazione IRCCS | Recruiting | Milan | 20133 | Italy |
| Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco | Recruiting | Milan | 20157 | Italy |
| Universita'Cattolica Del Sacro Cuore - UNICATT | Recruiting | Roma | 00168 | Italy |
| Leids Universitair Medisch Centrum (LUMC) | Recruiting | Leiden | 2333 ZE | Netherlands |
| Erasmus MC | Recruiting | Rotterdam | 3015AA | Netherlands |
| Auckland Eye Ltd | Recruiting | Auckland | 1050 | New Zealand |
| Hospital Universitario de Bellvitge | Recruiting | Barcelona | 08907 | Spain |
| Hospital Provincial de Conxo | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hospital Virgen Macarena | Recruiting | Seville | 41009 | Spain |
| Hospital Universitario Y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
| Moorfields Eye Hospital NHS Foundation Trust | Recruiting | London | EC1V 2PD | United Kingdom |
| Nhs Foundation Trust - Royal Hallamshire Hospital | Recruiting | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D005134 | Eye Neoplasms |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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