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

Last updated: April 15, 2025
Sponsor: Aura Biosciences
Overall Status: Active - Recruiting

Phase

3

Condition

Melanoma

Treatment

Suprachoroidal Microinjector

Sham Microinjector

Sham Infrared Laser

Clinical Study ID

NCT06007690
AU-011-301
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug or laser

  • Active ocular infection or disease

Study Design

Total Participants: 100
Treatment Group(s): 7
Primary Treatment: Suprachoroidal Microinjector
Phase: 3
Study Start date:
December 06, 2023
Estimated Completion Date:
March 01, 2027

Study 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.

Connect with a study center

  • Terrace Eye Centre

    Brisbane, Queensland 4000
    Australia

    Site Not Available

  • Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Alberta Health Services (AHS) Tom Baker Cancer Center

    Calgary, Alberta T2N4N2
    Canada

    Site Not Available

  • Serac Eye and Skin Care Centre

    Calgary, Alberta T2V 4Y8
    Canada

    Site Not Available

  • Princess Margaret Eye Tumour Clinic

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite Laval

    Québec City, Quebec G1S 4L8
    Canada

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Praha 4, Krč 14059
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Plzen

    Plzen, Plzenský Kraj 32300
    Czechia

    Active - Recruiting

  • Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha

    Praha 6, 16902
    Czechia

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice

    Nice, Cedex 1 06001
    France

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, 12203
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

    Lübeck, 23538
    Germany

    Active - Recruiting

  • The Chaim Sheba Medical Center

    Tel-Hashomer, HaMerkaz 5262100
    Israel

    Site Not Available

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZE
    Netherlands

    Active - Recruiting

  • Liverpool University Hospitals NHS Foundation Trust Broadgreen Hospital

    Liverpool, England L7 8XP
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital

    Liverpool, England L7 8XP
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital at City Road

    London, England EC1V 2PD
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Active - Recruiting

  • Nhs Foundation Trust - Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Active - Recruiting

  • Retina Consultants of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • UCSD Shiley Eye Institute, Jacobs Retina Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Doris Stein Eye Research Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University School of Medicine

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California 95825
    United States

    Active - Recruiting

  • UCSF Ocular Oncology Clinic

    San Francisco, California 94143
    United States

    Site Not Available

  • Colorado Retina Associates

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Bascom Palmer Eye Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Retina Associates of Florida, PA

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Emory Eye Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02116
    United States

    Site Not Available

  • Tufts Medical Center New England Eye Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • W.K. Kellogg Eye Center - University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Associated Retinal Consultants (ARC) P.C.

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • The Retina Institute

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Nebraska Medicine's Truhlsen Eye Institute

    Omaha, Nebraska 68105
    United States

    Active - Recruiting

  • New Jersey Retina Group

    Wayne, New Jersey 07470
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester, Flaum Eye Institute

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke Eye Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cole Eye Institute

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio State Ophthalmic Oncology Service

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Shields & Shields PC-Wills Eye Institute

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Thomas Jefferson University (TJU) - Wills Eye Institute

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Retina Consultants of Carolina

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Southeastern Retina Associates

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • University of Tennessee Hamilton Eye Institute

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • UT, Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Retina Associates of South Texas, P.A.

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77401
    United States

    Active - Recruiting

  • Moran Eye Center University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Retina Associates of Utah

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Vitreoretinal Associates of Washington

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • University of Wisconsin Madison

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.