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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
NCT06007690 · Aura Biosciences
In plain English
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About this study
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.
Eligibility criteria
Inclusion Criteria:
* Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
* Have no evidence of metastatic disease confirmed by imaging
* Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Exclusion Criteria:
* Have known contraindications or sensitivities to the study drug or laser
* Active ocular infection or disease
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-12-06
Estimated completion: 2028-08-15
Last updated: 2026-03-02
Interventions
Drug: Bel-sarDevice: Suprachoroidal MicroinjectorDevice: Infrared LaserDevice: Sham Infrared LaserDevice: Sham Microinjector
Primary outcomes
- • Time to reach tumor progression (65 weeks)
Sponsor
Aura Biosciences · industry
Contacts & investigators
ContactMedical Monitor · contact · clinical@aurabiosciences.com · 617-500-8864
InvestigatorMedical Monitor · study_director, Aura Biosciences
All locations (71)
Retina Consultants of AlabamaWithdrawn
Birmingham, Alabama, United States
UCSD Shiley Eye Institute, Jacobs Retina CenterRecruiting
La Jolla, California, United States
Doris Stein Eye Research CenterRecruiting
Los Angeles, California, United States
Stanford University School of MedicineRecruiting
Palo Alto, California, United States
Retinal Consultants Medical Group, Inc.Recruiting
Sacramento, California, United States
Bascom Palmer Eye InstituteWithdrawn
Miami, Florida, United States
Retina Associates of Florida, PARecruiting
Tampa, Florida, United States
Emory Eye CenterRecruiting
Atlanta, Georgia, United States
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Tufts Medical Center New England Eye CenterRecruiting
Boston, Massachusetts, United States
Massachusetts Eye and EarRecruiting
Boston, Massachusetts, United States
W.K. Kellogg Eye Center - University of MichiganRecruiting
Ann Arbor, Michigan, United States
Associated Retinal Consultants (ARC) P.C.Recruiting
Royal Oak, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Nebraska Medicine's Truhlsen Eye InstituteRecruiting
Omaha, Nebraska, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Duke Eye CenterRecruiting
Durham, North Carolina, United States
Cole Eye InstituteRecruiting
Cleveland, Ohio, United States
Dean McGee Eye InstituteRecruiting
Oklahoma City, Oklahoma, United States
Retina Consultants of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Shields & Shields PC-Wills Eye InstituteRecruiting
Philadelphia, Pennsylvania, United States
Retina Consultants of CarolinaRecruiting
Greenville, South Carolina, United States
Southeastern Retina AssociatesRecruiting
Chattanooga, Tennessee, United States
Tennessee Retina, PCRecruiting
Nashville, Tennessee, United States
Austin Retina AssociatesRecruiting
Austin, Texas, United States
Texas Retina AssociatesRecruiting
Dallas, Texas, United States
UT, Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Retina Associates of South Texas, P.A.Recruiting
San Antonio, Texas, United States
Retina Center of TexasRecruiting
Southlake, Texas, United States
Retina Consultants of TexasRecruiting
The Woodlands, Texas, United States
Retina Associates of UtahRecruiting
Salt Lake City, Utah, United States
Vitreoretinal Associates of WashingtonRecruiting
Bellevue, Washington, United States
Pacific NW RetinaRecruiting
Burlington, Washington, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
University of Wisconsin MadisonRecruiting
Madison, Wisconsin, United States
Terrace Eye CentreRecruiting
Brisbane, Queensland, Australia
Eye Research AustraliaRecruiting
East Melbourne, Victoria, Australia
Medical University GrazRecruiting
Graz, Austria
Medizinische Universität Wien, Department of Ophthalmology and OptometryRecruiting
Vienna, Austria
Cliniques universitaires Saint-LucRecruiting
Brussels, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Serac Eye and Skin Care CentreRecruiting
Calgary, Alberta, Canada
Centre Hospitalier de l'Universite LavalRecruiting
Québec, Quebec, Canada
Fakultni Thomayerova nemocniceRecruiting
Prague, Krč, Czechia
Fakultni nemocnice PlzenRecruiting
Pilsen, Plzenský Kraj, Czechia
Ustredni vojenska nemocnice Vojenska fakultni nemocnice PrahaRecruiting
Prague, Czechia
Centre Hospitalier Universitaire de NiceRecruiting
Nice, Cedex 1, France
Hospices Civils de Lyon - Hôpital de La Croix Rousse - HospitalRecruiting
Lyon, Rhone, France
Charité - Universitätsmedizin Berlin KöRRecruiting
Berlin, Germany
University Hospital Cologne (AöR)Not Yet Recruiting
Cologne, Germany
Universitätsmedizin EssenRecruiting
Essen, Germany
Uniklinikum Hamburg EppendorfRecruiting
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein Klinik für AugenheilkundeRecruiting
Lübeck, Germany
Klinikum der LMU MuenchenRecruiting
München, Germany
Universitätsklinikum TübingenRecruiting
Tübingen, Germany
The Chaim Sheba Medical CenterRecruiting
Tel-Hashomer, Central District, Israel
Hadassah Medical Center, Ein-KaremRecruiting
Jerusalem, Jerusalem, Israel
AOUC Azienda Ospedaliero-Universitaria CareggiRecruiting
Florence, Italy
Istituto Nazionale dei Tumori, Fondazione IRCCSRecruiting
Milan, Italy
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli SaccoRecruiting
Milan, Italy
Universita'Cattolica Del Sacro Cuore - UNICATTRecruiting
Roma, Italy
Leids Universitair Medisch Centrum (LUMC)Recruiting
Leiden, Netherlands
Erasmus MCRecruiting
Rotterdam, Netherlands
Auckland Eye LtdRecruiting
Auckland, New Zealand
Hospital Universitario de BellvitgeRecruiting
Barcelona, Spain
Hospital Provincial de ConxoRecruiting
Santiago de Compostela, Spain
Hospital Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitario Y Politécnico La FeRecruiting
Valencia, Spain
Moorfields Eye Hospital NHS Foundation TrustRecruiting
London, United Kingdom
Nhs Foundation Trust - Royal Hallamshire HospitalRecruiting
Sheffield, United Kingdom