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: November 21, 2025
Sponsor: Aura Biosciences
Overall Status: Active - Recruiting

Phase

3

Condition

Melanoma

Treatment

Bel-sar

Sham Treatment

Suprachoroidal Microinjector

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: Bel-sar
Phase: 3
Study Start date:
December 06, 2023
Estimated Completion Date:
August 15, 2028

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

  • Terrace Eye Centre

    Brisbane 2174003, Queensland 2152274 4000
    Australia

    Active - Recruiting

  • Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Eye Research Australia

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Active - Recruiting

  • Medical University Graz

    Graz 2778067, 8036
    Austria

    Active - Recruiting

  • Medizinische Universität Wien, Department of Ophthalmology and Optometry

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, 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

  • Serac Eye and Skin Care Centre

    Calgary 5913490, Alberta 5883102 T2V 4Y8
    Canada

    Active - Recruiting

  • Princess Margaret Eye Tumour Clinic

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Eye Tumour Clinic

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite Laval

    Québec City, Quebec G1S 4L8
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite Laval

    Québec 6325494, Quebec 6115047 G1S 4L8
    Canada

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Prague 3067696, Krč 14059
    Czechia

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Praha 4, Krč 14059
    Czechia

    Site Not Available

  • Fakultni nemocnice Plzen

    Pilsen 3068160, Plzenský Kraj 32300
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Plzen

    Plzen, Plzenský Kraj 32300
    Czechia

    Site Not Available

  • Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha

    Prague 3067696, 16902
    Czechia

    Active - Recruiting

  • Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha

    Praha 6, 16902
    Czechia

    Site Not Available

  • Centre Hospitalier Universitaire de Nice

    Nice, Cedex 1 06001
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice

    Nice 2990440, Cedex 1 06001
    France

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, 12203
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin KöR

    Berlin 2950159, 12203
    Germany

    Active - Recruiting

  • Uniklinikum Hamburg Eppendorf

    Hamburg 2911298, 20246
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

    Lübeck, 23538
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

    Lübeck 2875601, 23538
    Germany

    Active - Recruiting

  • Klinikum der LMU Muenchen

    München 2867711, 80336
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen 2820860, 72076
    Germany

    Active - Recruiting

  • The Chaim Sheba Medical Center

    Tel-Hashomer, Central District 294904 5262100
    Israel

    Active - Recruiting

  • Hadassah Medical Center, Ein-Karem

    Jerusalem 281184, Jerusalem 293198 9112001
    Israel

    Active - Recruiting

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence 3176959, 50134
    Italy

    Active - Recruiting

  • Istituto Nazionale dei Tumori, Fondazione IRCCS

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

    Milan 6951411, 20157
    Italy

    Active - Recruiting

  • Universita'Cattolica Del Sacro Cuore - UNICATT

    Roma 8957247, 00168
    Italy

    Active - Recruiting

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZE
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden 2751773, 2333 ZE
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015AA
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam 2747891, 3015AA
    Netherlands

    Active - Recruiting

  • Auckland Eye Ltd

    Auckland, 1050
    New Zealand

    Site Not Available

  • Auckland Eye Ltd

    Auckland 2193733, 1050
    New Zealand

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona 3128760, 08907
    Spain

    Active - Recruiting

  • Hospital Provincial de Conxo

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Provincial de Conxo

    Santiago de Compostela 3109642, 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politécnico La Fe

    Valencia 2509954, 46026
    Spain

    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

  • Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital

    Liverpool 2644210, England 6269131 L7 8XP
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London 2643743, EC1V 2PD
    United Kingdom

    Active - Recruiting

  • Nhs Foundation Trust - Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Nhs Foundation Trust - Royal Hallamshire Hospital

    Sheffield 2638077, S10 2JF
    United Kingdom

    Active - Recruiting

  • Retina Consultants of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Retina Consultants of Alabama

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • UCSD Shiley Eye Institute, Jacobs Retina Center

    La Jolla, California 92093
    United States

    Site Not Available

  • 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

    Site Not Available

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California 95825
    United States

    Site Not Available

  • UCSF Ocular Oncology Clinic

    San Francisco, California 94143
    United States

    Site Not Available

  • UCSD Shiley Eye Institute, Jacobs Retina Center

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • Doris Stein Eye Research Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Stanford University School of Medicine

    Palo Alto 5380748, California 5332921 94303
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group, Inc.

    Sacramento 5389489, California 5332921 95825
    United States

    Active - Recruiting

  • Colorado Retina Associates

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Bascom Palmer Eye Institute

    Miami, Florida 33136
    United States

    Site Not Available

  • Retina Associates of Florida, PA

    Tampa, Florida 33609
    United States

    Site Not Available

  • Bascom Palmer Eye Institute

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Retina Associates of Florida, PA

    Tampa 4174757, Florida 4155751 33609
    United States

    Active - Recruiting

  • Emory Eye Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory Eye Center

    Atlanta 4180439, Georgia 4197000 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

    Site Not Available

  • University of Illinois at Chicago

    Chicago 4887398, Illinois 4896861 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

    Site Not Available

  • Massachusetts Eye and Ear

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Tufts Medical Center New England Eye Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Active - Recruiting

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

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Associated Retinal Consultants (ARC) P.C.

    Royal Oak, Michigan 48073
    United States

    Site Not Available

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

    Ann Arbor 4984247, Michigan 5001836 48105
    United States

    Active - Recruiting

  • Associated Retinal Consultants (ARC) P.C.

    Royal Oak 5007804, Michigan 5001836 48073
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 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

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Nebraska Medicine's Truhlsen Eye Institute

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Nebraska Medicine's Truhlsen Eye Institute

    Omaha 5074472, Nebraska 5073708 68105
    United States

    Active - Recruiting

  • New Jersey Retina Group

    Wayne, New Jersey 07470
    United States

    Site Not Available

  • New Jersey Retina Group

    Wayne 5106160, New Jersey 5101760 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

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Duke Eye Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke Eye Center

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • Cole Eye Institute

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State Ophthalmic Oncology Service

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Cole Eye Institute

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Dean McGee Eye Institute

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Active - Recruiting

  • Retina Consultants of Oklahoma

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Active - Recruiting

  • Shields & Shields PC-Wills Eye Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University (TJU) - Wills Eye Institute

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Shields & Shields PC-Wills Eye Institute

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • Retina Consultants of Carolina

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Retina Consultants of Carolina

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Active - Recruiting

  • Southeastern Retina Associates

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • University of Tennessee Hamilton Eye Institute

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Southeastern Retina Associates

    Chattanooga 4612862, Tennessee 4662168 37421
    United States

    Active - Recruiting

  • Tennessee Retina, PC

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • UT, Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Retina Associates of South Texas, P.A.

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 77401
    United States

    Site Not Available

  • Austin Retina Associates

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • UT, Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • Retina Associates of South Texas, P.A.

    San Antonio 4726206, Texas 4736286 78240
    United States

    Active - Recruiting

  • Retina Center of Texas

    Southlake 4733313, Texas 4736286 76092
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands 4736476, Texas 4736286 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

  • Retina Associates of Utah

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Active - Recruiting

  • Vitreoretinal Associates of Washington

    Bellevue, Washington 98004
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Vitreoretinal Associates of Washington

    Bellevue 5786882, Washington 5815135 98004
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

  • University of Wisconsin Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • University of Wisconsin Madison

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Active - Recruiting

Map preview placeholder

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.