RecruitingPhase 3NCT06007690

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

Sponsor

Aura Biosciences

Enrollment

100 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Uveal Melanoma Choroidal Melanoma Indeterminate Lesions Ocular 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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new light-activated treatment called belzupacap sarotalocan (AU-011) injected into the eye for people with a small or uncertain spot on the back of the eye (choroid) that may be an early-stage eye melanoma — to try to destroy the tumor while preserving vision. **You may be eligible if:** - You have been diagnosed with a primary indeterminate lesion or small choroidal melanoma (a suspicious or small cancerous spot at the back of the eye) - There is no evidence that the cancer has spread to other parts of your body - You have not previously received treatment for this lesion (except possibly photodynamic therapy) **You may NOT be eligible if:** - You have a known allergy or sensitivity to the study drug or the laser used - You have an active eye infection or other active eye disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(71)

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

Stanford University School of Medicine

Palo Alto, California, United States

Retinal Consultants Medical Group, Inc.

Sacramento, California, 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

St Louis, Missouri, United States

Nebraska Medicine's Truhlsen Eye Institute

Omaha, Nebraska, 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

Retina Consultants of Oklahoma

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

Pacific NW Retina

Burlington, 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

Medical University Graz

Graz, Austria

Medizinische Universität Wien, Department of Ophthalmology and Optometry

Vienna, Austria

Cliniques universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Serac Eye and Skin Care Centre

Calgary, Alberta, Canada

Centre Hospitalier de l'Universite Laval

Québec, Quebec, Canada

Fakultni Thomayerova nemocnice

Prague, Krč, Czechia

Fakultni nemocnice Plzen

Pilsen, Plzenský Kraj, Czechia

Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha

Prague, Czechia

Centre Hospitalier Universitaire de Nice

Nice, Cedex 1, France

Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital

Lyon, Rhone, France

Charité - Universitätsmedizin Berlin KöR

Berlin, Germany

University Hospital Cologne (AöR)

Cologne, Germany

Universitätsmedizin Essen

Essen, Germany

Uniklinikum Hamburg Eppendorf

Hamburg, Germany

Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

Lübeck, Germany

Klinikum der LMU Muenchen

München, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

The Chaim Sheba Medical Center

Tel-Hashomer, Central District, Israel

Hadassah Medical Center, Ein-Karem

Jerusalem, Jerusalem, Israel

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Istituto Nazionale dei Tumori, Fondazione IRCCS

Milan, Italy

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

Milan, Italy

Universita'Cattolica Del Sacro Cuore - UNICATT

Roma, Italy

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

Auckland Eye Ltd

Auckland, New Zealand

Hospital Universitario de Bellvitge

Barcelona, Spain

Hospital Provincial de Conxo

Santiago de Compostela, Spain

Hospital Virgen Macarena

Seville, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Spain

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Nhs Foundation Trust - Royal Hallamshire Hospital

Sheffield, United Kingdom

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