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
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.
Arms & interventions
- DrugBel-sar
Bel-sar via suprachoroidal administration followed by laser application.
- DeviceSuprachoroidal Microinjector
Suprachoroidal injection device
- DeviceInfrared Laser
Laser application
- DeviceSham Infrared Laser
Sham laser application
- DeviceSham Microinjector
Sham injection device
Outcome measures
Primary
Time to reach tumor progression
Tumor Progression
Time frame: 65 weeks
Secondary
Time to composite endpoint
Time frame: 65 weeks
Eligibility criteria
Study locations (36)
Retina Consultants of Alabama
Birmingham, Alabama, 35233
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, 92093
Doris Stein Eye Research Center
Los Angeles, California, 90095
Stanford University School of Medicine
Palo Alto, California, 94303
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825
Bascom Palmer Eye Institute
Miami, Florida, 33136
Retina Associates of Florida, PA
Tampa, Florida, 33609
Emory Eye Center
Atlanta, Georgia, 30322
University of Illinois at Chicago
Chicago, Illinois, 60612
Tufts Medical Center New England Eye Center
Boston, Massachusetts, 02111
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105
Associated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, 48073
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Nebraska Medicine's Truhlsen Eye Institute
Omaha, Nebraska, 68105
Columbia University Irving Medical Center
New York, New York, 10032
Duke Eye Center
Durham, North Carolina, 27705
Cole Eye Institute
Cleveland, Ohio, 44195
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112
Shields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Retina Consultants of Carolina
Greenville, South Carolina, 29605
Southeastern Retina Associates
Chattanooga, Tennessee, 37421
Tennessee Retina, PC
Nashville, Tennessee, 37203
Austin Retina Associates
Austin, Texas, 78705
Texas Retina Associates
Dallas, Texas, 75231
UT, Southwestern Medical Center
Dallas, Texas, 75390
Retina Associates of South Texas, P.A.
San Antonio, Texas, 78240
Retina Center of Texas
Southlake, Texas, 76092
Retina Consultants of Texas
The Woodlands, Texas, 77401
Retina Associates of Utah
Salt Lake City, Utah, 84107
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004
Pacific NW Retina
Burlington, Washington, 98233
University of Washington Medical Center
Seattle, Washington, 98104
University of Wisconsin Madison
Madison, Wisconsin, 53705