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
- Conditions
- Ocular MelanomaUveal MelanomaChoroidal MelanomaIndeterminate Lesions
- Interventions
- Drug: Bel-sarDevice: Sham Infrared LaserDevice: Suprachoroidal MicroinjectorDevice: Sham MicroinjectorDevice: Infrared Laser
- Registration Number
- NCT06007690
- Lead Sponsor
- Aura Biosciences
- 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose bel-sar treatment arm & laser application Bel-sar High dose of bel-sar + laser application High dose bel-sar treatment arm & laser application Suprachoroidal Microinjector High dose of bel-sar + laser application High dose bel-sar treatment arm & laser application Infrared Laser High dose of bel-sar + laser application Low dose bel-sar treatment arm & laser application Bel-sar Low dose of bel-sar + laser application Low dose bel-sar treatment arm & laser application Suprachoroidal Microinjector Low dose of bel-sar + laser application Low dose bel-sar treatment arm & laser application Infrared Laser Low dose of bel-sar + laser application Sham control arm & sham laser Sham Infrared Laser Sham injection + sham laser Sham control arm & sham laser Sham Microinjector Sham injection + sham laser
- Primary Outcome Measures
Name Time Method Time to reach tumor progression 65 weeks Tumor Progression
- Secondary Outcome Measures
Name Time Method Time to composite endpoint 65 weeks Tumor progression or visual acuity failure
Trial Locations
- Locations (46)
Nebraska Medicine's Truhlsen Eye Institute
🇺🇸Omaha, Nebraska, United States
New Jersey Retina Group
🇺🇸Wayne, New Jersey, 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
Serac Eye and Skin Care Centre
🇨🇦Calgary, Alberta, Canada
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Colorado Retina Associates
🇺🇸Lakewood, Colorado, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Retina Associates of Florida, PA
🇺🇸Tampa, Florida, United States
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
Associated Retinal Consultants (ARC) P.C.
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, 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
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
Princess Margaret Eye Tumour Clinic
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite Laval
🇨🇦Québec City, Quebec, Canada
The Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, HaMerkaz, Israel
Hadassah Medical Center, Ein-Karem
🇮🇱Jerusalem, Yerushalayim, Israel
Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital
🇬🇧Liverpool, England, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Nhs Foundation Trust - Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom