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 (CoMpass)

July 30, 2026 updated by: Aura Biosciences
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Eye Research Australia
  • Austria
      • Graz, Austria, 8036
        • Medical University Graz
      • Vienna, Austria, 1090
        • Medizinische Universität Wien, Department of Ophthalmology and Optometry
  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4Y8
        • Serac Eye and Skin Care Centre
    • Quebec
      • Québec, Quebec, Canada, G1S 4L8
        • Centre Hospitalier de l'Universite Laval
  • Czechia
      • Prague, Czechia, 16902
        • Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
    • Krč
      • Prague, Krč, Czechia, 14059
        • Fakultni Thomayerova nemocnice
    • Plzenský Kraj
      • Pilsen, Plzenský Kraj, Czechia, 32300
        • Fakultni nemocnice Plzen
  • France
    • Cedex 1
      • Nice, Cedex 1, France, 06001
        • Centre Hospitalier Universitaire de Nice
    • Rhone
      • Lyon, Rhone, France, 69004
        • Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital
  • Germany
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin KöR
      • Cologne, Germany, 50937
        • University Hospital Cologne (AöR)
      • Essen, Germany, 45147
        • Universitätsmedizin Essen
      • Hamburg, Germany, 20246
        • Uniklinikum Hamburg Eppendorf
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
      • München, Germany, 80336
        • Klinikum der LMU Muenchen
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
  • Israel
    • Central District
      • Tel-Hashomer, Central District, Israel, 5262100
        • The Chaim Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Hadassah Medical Center, Ein-Karem
  • Italy
      • Florence, Italy, 50134
        • AOUC Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy, 20133
        • Istituto Nazionale dei Tumori, Fondazione IRCCS
      • Milan, Italy, 20157
        • Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
      • Roma, Italy, 00168
        • Universita'Cattolica Del Sacro Cuore - UNICATT
  • Netherlands
      • Leiden, Netherlands, 2333 ZE
        • Leids Universitair Medisch Centrum (LUMC)
      • Rotterdam, Netherlands, 3015AA
        • Erasmus MC
  • New Zealand
      • Auckland, New Zealand, 1050
        • Auckland Eye Ltd
  • Spain
      • Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Santiago de Compostela, Spain, 15706
        • Hospital Provincial de Conxo
      • Seville, Spain, 41009
        • Hospital Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe
  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Sheffield, United Kingdom, S10 2JF
        • Nhs Foundation Trust - Royal Hallamshire Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Shiley Eye Institute, Jacobs Retina Center
      • Los Angeles, California, United States, 90095
        • Doris Stein Eye Research Center
      • Palo Alto, California, United States, 94303
        • Stanford University School of Medicine
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group, Inc.
    • Florida
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida, PA
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center New England Eye Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • W.K. Kellogg Eye Center - University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants (ARC) P.C.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Nebraska Medicine's Truhlsen Eye Institute
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cole Eye Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute
      • Oklahoma City, Oklahoma, United States, 73112
        • Retina Consultants of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Shields & Shields PC-Wills Eye Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Retina Consultants of Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Southeastern Retina Associates
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina, PC
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas, P.A.
      • Southlake, Texas, United States, 76092
        • Retina Center of Texas
      • The Woodlands, Texas, United States, 77401
        • Retina Consultants of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
    • Washington
      • Bellevue, Washington, United States, 98004
        • Vitreoretinal Associates of Washington
      • Burlington, Washington, United States, 98233
        • Pacific NW Retina
      • Seattle, Washington, United States, 98104
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
Device: Suprachoroidal Microinjector
Suprachoroidal injection device
Other Names:
  • SCS Microinjector
Device: Infrared Laser
Laser application
Drug: Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Other Names:
  • AU-011
Experimental: Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
Device: Suprachoroidal Microinjector
Suprachoroidal injection device
Other Names:
  • SCS Microinjector
Device: Infrared Laser
Laser application
Drug: Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Other Names:
  • AU-011
Sham Comparator: Sham control arm & sham laser
Sham injection + sham laser
Device: Sham Infrared Laser
Sham laser application
Device: Sham Microinjector
Sham injection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach tumor progression
Time Frame: 65 weeks
Tumor Progression
65 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to composite endpoint
Time Frame: 65 weeks
Tumor progression or visual acuity failure
65 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aura Biosciences

Investigators

  • Study Director: Medical Monitor, Aura Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

August 15, 2028

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-011-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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