A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
NCT ID: NCT06007690
Last Updated: 2025-11-24
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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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2023-12-06
2028-08-15
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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High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal Microinjector
Suprachoroidal injection device
Infrared Laser
Laser application
Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal Microinjector
Suprachoroidal injection device
Infrared Laser
Laser application
Sham control arm & sham laser
Sham injection + sham laser
Sham Infrared Laser
Sham laser application
Sham Microinjector
Sham injection device
Interventions
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Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal Microinjector
Suprachoroidal injection device
Infrared Laser
Laser application
Sham Infrared Laser
Sham laser application
Sham Microinjector
Sham injection device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have no evidence of metastatic disease confirmed by imaging
* Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Exclusion Criteria
* Active ocular infection or disease
18 Years
ALL
No
Sponsors
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Aura Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Aura Biosciences
Locations
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Emory Eye Center
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Tufts Medical Center New England Eye Center
Boston, Massachusetts, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, United States
Retina Consultants of Alabama
Birmingham, Alabama, United States
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States
Doris Stein Eye Research Center
Los Angeles, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Retina Associates of Florida, PA
Tampa, Florida, United States
Associated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Nebraska Medicine's Truhlsen Eye Institute
Omaha, Nebraska, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke Eye Center
Durham, North Carolina, United States
Cole Eye Institute
Cleveland, Ohio, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, United States
Shields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina
Greenville, South Carolina, United States
Southeastern Retina Associates
Chattanooga, Tennessee, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Austin Retina Associates
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
UT, Southwestern Medical Center
Dallas, Texas, United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Terrace Eye Centre
Brisbane, Queensland, Australia
Eye Research Australia
East Melbourne, Victoria, Australia
Medical University Graz
Graz, , Austria
Medizinische Universität Wien, Department of Ophthalmology and Optometry
Vienna, , Austria
UZ Leuven
Leuven, , Belgium
Serac Eye and Skin Care Centre
Calgary, Alberta, Canada
Princess Margaret Eye Tumour Clinic
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite Laval
Québec, Quebec, Canada
Fakultni Thomayerova nemocnice
Prague, Krč, Czechia
Fakultni nemocnice Plzen
Pilsen, Plzenský Kraj, Czechia
Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
Prague, , Czechia
Centre Hospitalier Universitaire de Nice
Nice, Cedex 1, France
Charité - Universitätsmedizin Berlin KöR
Berlin, , Germany
Uniklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
Lübeck, , Germany
Klinikum der LMU Muenchen
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
The Chaim Sheba Medical Center
Tel-Hashomer, Central District, Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, Jerusalem, Israel
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Istituto Nazionale dei Tumori, Fondazione IRCCS
Milan, , Italy
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, , Italy
Universita'Cattolica Del Sacro Cuore - UNICATT
Roma, , Italy
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Auckland Eye Ltd
Auckland, , New Zealand
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Provincial de Conxo
Santiago de Compostela, , Spain
Hospital Universitario Y Politécnico La Fe
Valencia, , Spain
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Nhs Foundation Trust - Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Related Links
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Aura Biosciences
Other Identifiers
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AU-011-301
Identifier Type: -
Identifier Source: org_study_id
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