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
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Alabama
Retina Consultants of Alabama
RECRUITING
Birmingham
California
UCSD Shiley Eye Institute, Jacobs Retina Center
RECRUITING
La Jolla
Doris Stein Eye Research Center
NOT_YET_RECRUITING
Los Angeles
Stanford University School of Medicine
RECRUITING
Palo Alto
Retinal Consultants Medical Group, Inc.
RECRUITING
Sacramento
Florida
Bascom Palmer Eye Institute
RECRUITING
Miami
Retina Associates of Florida, PA
RECRUITING
Tampa
Georgia
Emory Eye Center
RECRUITING
Atlanta
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Tufts Medical Center New England Eye Center
RECRUITING
Boston
Michigan
W.K. Kellogg Eye Center - University of Michigan
RECRUITING
Ann Arbor
Associated Retinal Consultants (ARC) P.C.
RECRUITING
Royal Oak
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University
NOT_YET_RECRUITING
St Louis
North Carolina
Duke Eye Center
RECRUITING
Durham
Nebraska
Nebraska Medicine's Truhlsen Eye Institute
RECRUITING
Omaha
New Jersey
New Jersey Retina Group
NOT_YET_RECRUITING
Wayne
New York
Columbia University Irving Medical Center
NOT_YET_RECRUITING
New York
Ohio
Cole Eye Institute
RECRUITING
Cleveland
Oklahoma
Dean McGee Eye Institute
RECRUITING
Oklahoma City
Pennsylvania
Shields & Shields PC-Wills Eye Institute
RECRUITING
Philadelphia
South Carolina
Retina Consultants of Carolina
RECRUITING
Greenville
Tennessee
Southeastern Retina Associates
RECRUITING
Chattanooga
Tennessee Retina, PC
RECRUITING
Nashville
Texas
Austin Retina Associates
RECRUITING
Austin
Texas Retina Associates
RECRUITING
Dallas
UT, Southwestern Medical Center
RECRUITING
Dallas
Retina Associates of South Texas, P.A.
RECRUITING
San Antonio
Retina Center of Texas
RECRUITING
Southlake
Retina Consultants of Texas
RECRUITING
The Woodlands
Utah
Retina Associates of Utah
RECRUITING
Salt Lake City
Washington
Vitreoretinal Associates of Washington
RECRUITING
Bellevue
University of Washington Medical Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin Madison
RECRUITING
Madison
Other Locations
Australia
Terrace Eye Centre
RECRUITING
Brisbane
Eye Research Australia
RECRUITING
East Melbourne
Austria
Medizinische Universität Wien, Department of Ophthalmology and Optometry
RECRUITING
Vienna
Belgium
UZ Leuven
RECRUITING
Leuven
Canada
Serac Eye and Skin Care Centre
NOT_YET_RECRUITING
Calgary
Centre Hospitalier de l'Universite Laval
RECRUITING
Québec
Princess Margaret Eye Tumour Clinic
NOT_YET_RECRUITING
Toronto
France
Centre Hospitalier Universitaire de Nice
RECRUITING
Nice
Germany
Charité - Universitätsmedizin Berlin KöR
RECRUITING
Berlin
Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
RECRUITING
Lübeck
Klinikum der LMU Muenchen
RECRUITING
München
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Israel
Hadassah Medical Center, Ein-Karem
RECRUITING
Jerusalem
The Chaim Sheba Medical Center
RECRUITING
Tel-hashomer
Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
RECRUITING
Milan
Universita'Cattolica Del Sacro Cuore - UNICATT
RECRUITING
Roma
Netherlands
Leids Universitair Medisch Centrum (LUMC)
RECRUITING
Leiden
Erasmus MC
RECRUITING
Rotterdam
New Zealand
Auckland Eye Ltd
RECRUITING
Auckland
Spain
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Provincial de Conxo
RECRUITING
Santiago De Compostela
United Kingdom
Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital
NOT_YET_RECRUITING
Liverpool
Moorfields Eye Hospital NHS Foundation Trust
RECRUITING
London
Nhs Foundation Trust - Royal Hallamshire Hospital
RECRUITING
Sheffield
Contact Information
Primary
Medical Monitor
clinical@aurabiosciences.com
617-500-8864
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 100
Treatments
Experimental: High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
Experimental: Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
Sham_comparator: Sham control arm & sham laser
Sham injection + sham laser
Related Therapeutic Areas
Sponsors
Leads: Aura Biosciences