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
CoMpass
1 other identifier
interventional
108
13 countries
65
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2023
Longer than P75 for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedStudy Start
First participant enrolled
December 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2028
July 31, 2026
July 1, 2026
3.9 years
August 17, 2023
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to reach tumor progression
Tumor Progression
65 weeks
Secondary Outcomes (1)
Time to composite endpoint
65 weeks
Study Arms (3)
High dose bel-sar treatment arm & laser application
EXPERIMENTALHigh dose of bel-sar + laser application
Low dose bel-sar treatment arm & laser application
EXPERIMENTALLow dose of bel-sar + laser application
Sham control arm & sham laser
SHAM COMPARATORSham injection + sham laser
Interventions
Bel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal injection device
Laser application
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aura Bioscienceslead
Study Sites (66)
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, 92093, United States
Doris Stein Eye Research Center
Los Angeles, California, 90095, United States
Stanford University School of Medicine
Palo Alto, California, 94303, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825, United States
Retina Associates of Florida, PA
Tampa, Florida, 33609, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Tufts Medical Center New England Eye Center
Boston, Massachusetts, 02111, United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114, United States
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105, United States
Associated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Nebraska Medicine's Truhlsen Eye Institute
Omaha, Nebraska, 68105, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Cole Eye Institute
Cleveland, Ohio, 44195, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112, United States
Shields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants of Carolina
Greenville, South Carolina, 29605, United States
Southeastern Retina Associates
Chattanooga, Tennessee, 37421, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, 78240, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Retina Consultants of Texas
The Woodlands, Texas, 77401, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004, United States
Pacific NW Retina
Burlington, Washington, 98233, United States
University of Washington Medical Center
Seattle, Washington, 98104, United States
University of Wisconsin Madison
Madison, Wisconsin, 53705, United States
Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Medical University Graz
Graz, 8036, Austria
Medizinische Universität Wien, Department of Ophthalmology and Optometry
Vienna, 1090, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, 3000, Belgium
Serac Eye and Skin Care Centre
Calgary, Alberta, T2V 4Y8, Canada
Centre Hospitalier de l'Universite Laval
Québec, Quebec, G1S 4L8, Canada
Fakultni Thomayerova nemocnice
Prague, Krč, 14059, Czechia
Fakultni nemocnice Plzen
Pilsen, Plzenský Kraj, 32300, Czechia
Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
Prague, 16902, Czechia
Centre Hospitalier Universitaire de Nice
Nice, Cedex 1, 06001, France
Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital
Lyon, Rhone, 69004, France
Charité - Universitätsmedizin Berlin KöR
Berlin, 12203, Germany
University Hospital Cologne (AöR)
Cologne, 50937, Germany
Universitätsmedizin Essen
Essen, 45147, Germany
Uniklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
Lübeck, 23538, Germany
Klinikum der LMU Muenchen
München, 80336, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
The Chaim Sheba Medical Center
Tel-Hashomer, Central District, 5262100, Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, Jerusalem, 9112001, Israel
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
Istituto Nazionale dei Tumori, Fondazione IRCCS
Milan, 20133, Italy
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, 20157, Italy
Universita'Cattolica Del Sacro Cuore - UNICATT
Roma, 00168, Italy
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZE, Netherlands
Erasmus MC
Rotterdam, 3015AA, Netherlands
Auckland Eye Ltd
Auckland, 1050, New Zealand
Hospital Universitario de Bellvitge
Barcelona, 08907, Spain
Hospital Provincial de Conxo
Santiago de Compostela, 15706, Spain
Hospital Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Y Politécnico La Fe
Valencia, 46026, Spain
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
Nhs Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Aura Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Subject, Assessor, and Sponsor masked trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2023
First Posted
August 23, 2023
Study Start
December 6, 2023
Primary Completion (Estimated)
November 15, 2027
Study Completion (Estimated)
August 15, 2028
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share