A New Treatment for Early-Stage Eye Melanoma Using a Special Injection and Laser
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
In Plain English
This trial is testing a new treatment called belzupacap sarotalocan (bel-sar) for people with early-stage uveal melanoma or suspicious spots in the eye that might become cancer. The treatment works in two steps: first, doctors inject the medication into a specific space behind your eye using a tiny needle, and then they activate it with a special infrared laser. The goal is to destroy cancer cells while preserving your vision. You'll be randomly assigned to either receive the real treatment or a sham (fake) treatment—meaning you'll go through the same procedure, but some people won't receive the active drug or laser. Neither you nor your doctors will know which group you're in during the trial, which helps ensure fair results. This trial is testing whether bel-sar is safe and actually works better than doing nothing, so researchers can understand if this new approach is worth offering to patients like you.
What This Trial Does
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).
How It Works
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.
Who Can Join
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
Treatments
Bel-sar (DRUG)
Bel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal Microinjector (DEVICE)
Suprachoroidal injection device
Infrared Laser (DEVICE)
Laser application
Sham Infrared Laser (DEVICE)
Sham laser application
Sham Microinjector (DEVICE)
Sham injection device
Trial Sites (71)
Retina Consultants of Alabama
Birmingham, Alabama, United States
WithdrawnUCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States
RecruitingDoris Stein Eye Research Center
Los Angeles, California, United States
RecruitingStanford University School of Medicine
Palo Alto, California, United States
RecruitingRetinal Consultants Medical Group, Inc.
Sacramento, California, United States
RecruitingBascom Palmer Eye Institute
Miami, Florida, United States
WithdrawnRetina Associates of Florida, PA
Tampa, Florida, United States
RecruitingEmory Eye Center
Atlanta, Georgia, United States
RecruitingUniversity of Illinois at Chicago
Chicago, Illinois, United States
RecruitingTufts Medical Center New England Eye Center
Boston, Massachusetts, United States
RecruitingMassachusetts Eye and Ear
Boston, Massachusetts, United States
RecruitingW.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, United States
RecruitingAssociated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, United States
RecruitingMayo Clinic
Rochester, Minnesota, United States
RecruitingWashington University
St Louis, Missouri, United States
RecruitingNebraska Medicine's Truhlsen Eye Institute
Omaha, Nebraska, United States
RecruitingColumbia University Irving Medical Center
New York, New York, United States
RecruitingDuke Eye Center
Durham, North Carolina, United States
RecruitingCole Eye Institute
Cleveland, Ohio, United States
RecruitingDean McGee Eye Institute
Oklahoma City, Oklahoma, United States
RecruitingRetina Consultants of Oklahoma
Oklahoma City, Oklahoma, United States
RecruitingShields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, United States
RecruitingRetina Consultants of Carolina
Greenville, South Carolina, United States
RecruitingSoutheastern Retina Associates
Chattanooga, Tennessee, United States
RecruitingTennessee Retina, PC
Nashville, Tennessee, United States
RecruitingAustin Retina Associates
Austin, Texas, United States
RecruitingTexas Retina Associates
Dallas, Texas, United States
RecruitingUT, Southwestern Medical Center
Dallas, Texas, United States
RecruitingRetina Associates of South Texas, P.A.
San Antonio, Texas, United States
RecruitingRetina Center of Texas
Southlake, Texas, United States
RecruitingRetina Consultants of Texas
The Woodlands, Texas, United States
RecruitingRetina Associates of Utah
Salt Lake City, Utah, United States
RecruitingVitreoretinal Associates of Washington
Bellevue, Washington, United States
RecruitingPacific NW Retina
Burlington, Washington, United States
RecruitingUniversity of Washington Medical Center
Seattle, Washington, United States
RecruitingUniversity of Wisconsin Madison
Madison, Wisconsin, United States
RecruitingTerrace Eye Centre
Brisbane, Queensland, Australia
RecruitingEye Research Australia
East Melbourne, Victoria, Australia
RecruitingMedical University Graz
Graz, Austria
RecruitingMedizinische Universität Wien, Department of Ophthalmology and Optometry
Vienna, Austria
RecruitingCliniques universitaires Saint-Luc
Brussels, Belgium
RecruitingUZ Leuven
Leuven, Belgium
RecruitingSerac Eye and Skin Care Centre
Calgary, Alberta, Canada
RecruitingCentre Hospitalier de l'Universite Laval
Québec, Quebec, Canada
RecruitingFakultni Thomayerova nemocnice
Prague, Krč, Czechia
RecruitingFakultni nemocnice Plzen
Pilsen, Plzenský Kraj, Czechia
RecruitingUstredni vojenska nemocnice Vojenska fakultni nemocnice Praha
Prague, Czechia
RecruitingCentre Hospitalier Universitaire de Nice
Nice, Cedex 1, France
RecruitingHospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital
Lyon, Rhone, France
RecruitingCharité - Universitätsmedizin Berlin KöR
Berlin, Germany
RecruitingUniversity Hospital Cologne (AöR)
Cologne, Germany
Not Yet RecruitingUniversitätsmedizin Essen
Essen, Germany
RecruitingUniklinikum Hamburg Eppendorf
Hamburg, Germany
RecruitingUniversitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
Lübeck, Germany
RecruitingKlinikum der LMU Muenchen
München, Germany
RecruitingUniversitätsklinikum Tübingen
Tübingen, Germany
RecruitingThe Chaim Sheba Medical Center
Tel-Hashomer, Central District, Israel
RecruitingHadassah Medical Center, Ein-Karem
Jerusalem, Jerusalem, Israel
RecruitingAOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
RecruitingIstituto Nazionale dei Tumori, Fondazione IRCCS
Milan, Italy
RecruitingOspedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, Italy
RecruitingUniversita'Cattolica Del Sacro Cuore - UNICATT
Roma, Italy
RecruitingLeids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
RecruitingErasmus MC
Rotterdam, Netherlands
RecruitingAuckland Eye Ltd
Auckland, New Zealand
RecruitingHospital Universitario de Bellvitge
Barcelona, Spain
RecruitingHospital Provincial de Conxo
Santiago de Compostela, Spain
RecruitingHospital Virgen Macarena
Seville, Spain
RecruitingHospital Universitario Y Politécnico La Fe
Valencia, Spain
RecruitingMoorfields Eye Hospital NHS Foundation Trust
London, United Kingdom
RecruitingNhs Foundation Trust - Royal Hallamshire Hospital
Sheffield, United Kingdom
Recruiting